CN102209490A

CN102209490A - Apparatus and display methods relating to intravascular placement of a catheter

Info

Publication number: CN102209490A
Application number: CN2009801446638A
Authority: CN
Inventors: J·B·考克斯; C·W·克鲁克; A·K·米森纳; P·D·摩根; D·R·莫里斯
Original assignee: CR Bard Inc
Current assignee: CR Bard Inc
Priority date: 2008-09-10
Filing date: 2009-09-10
Publication date: 2011-10-05
Anticipated expiration: 2029-09-10
Also published as: EP2337491A4; ES2558695T3; US20090234328A1; EP2337491B1; US9649048B2; US10849695B2; CN102209490B; WO2010030820A1; US20170231700A1; EP2337491A1

Abstract

An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. Various aspects for visualizing and manipulating display of the ECG signal data acquired via the present system, together with aspects of various ECG sensor configurations, are also disclosed.

Description

Place relevant apparatus and display packing with the conduit in the vascular system

Cross reference to related application: the application requires the U.S. Provisional Patent Application No.61/095 of the exercise question of JIUYUE in 2008 submission on the 10th for " system and method (System and Method for Placing a Catheter Within a Vasculature of a Patient) that is used for placement conduit in patient's vascular system ", 921 priority.The application still is the exercise question submitted on April 17th, the 2009 U. S. application No.12/426 for " being used to pass the system and method (Systems and Methods for Breaching a Sterile Field for Intravascular Placement of a Catheter) that aseptic area is placed with the conduit that carries out in the vascular system ", 175 part continuation application, this application No.12/426,175 is that the exercise question of submitting on November 25th, 2008 is the U.S. Patent application No.12/323 of " being used for the integrated system (Integrated System for Intravascular Placement of a Catheter) that the conduit in the vascular system is placed ", 273 part continuation application, this application No.12/323,273 require the priority of following U.S. Provisional Patent Application: the exercise question of submitting on November 26th, 2007 is the application No.60/990 of " being used for the integrated ultrasonic and terminal navigation system (Integrated Ultrasound and Tip Location System for Intravascular Placement of a Catheter) that the conduit in the vascular system is placed ", 242, the exercise question of JIUYUE in 2008 submission on the 10th is the application No.61/095 of " being used for placing in patient's vascular system the system and method (System and Method for Placing a Catheter Within a Vasculature of a Patient) of conduit ", 921, the exercise question of submitting on August 22nd, 2008 is the application No.61/091 of " comprise prepackage can handle the conduit of probe (Catheter Including Preloaded Steerable Stylet) ", 233, the exercise question that JIUYUE in 2008 was submitted on the 9th is the application No.61/095 of " comprise ECG and based on the conduit tube component (Catheter Assembly Including ECG and Magnetic-Based Sensor Stylet) of the probe of Magnetic Sensor ", 451, and the exercise question of submission on April 17th, 2008 is the application No.61/045 of " passing the electrical cnnector (Drape-Breaching Electrical Connector) of cloth list ", 944.The full content of each application that this paper quotes the front is by reference incorporated the application into.

Summary of the invention

Brief overview, embodiment of the present invention relate to integrated catheter placement system, and described system is configured to place exactly conduit in patient's vascular system.Described integrated system adopts at least two kinds of forms to improve the accuracy that conduit is placed: the ultrasonic aid in guide that 1) is used for conduit is imported patient's vascular system; And 2) terminal navigation system (" TLS "), or follow the trail of by (for example permanent magnet or the electromagnet) based on the magnetic mode to catheter tip in the progradation of vascular system at conduit, in such progradation, to survey and convenient correction to any terminal dislocation.

In one embodiment, integrated system comprises the system control position with processor controls, is used for being placed on the terminal alignment sensor on patient's the part of body temporarily, and ultrasonic detector.Described terminal alignment sensor is surveyed the magnetic field that is arranged on the probe in the conduit cavity when conduit is set in the vascular system.Before conduit imported vascular system, ultrasonic detector was with the part of ultrasonic power imaging vascular system.In addition, ultrasonic detector comprises the user input control device, and described user input control device is used for being controlled at the use and the use of the terminal alignment sensor in the station-keeping mode endways of the ultrasonic detector of ultrasound mode.

In another embodiment, the third mode, that is, guiding is included in the described system based on the catheter tip of ECG signal, to enable the desired locations with respect to the patient's who produces the ECG signal heart knot (a node of the patient ' s heart) that guides to of catheter tip.Also disclose and be used between patient's aseptic area and non-sterile zone, setting up conductive path to enable the various devices of ECG signal path from conduit to terminal alignment sensor.Such device comprises, for example sets up the connectivity scenario of conductive path by the perforation that limits in sterile barrier (for example surgical operation cloth list), and wherein the connectivity scenario isolation of will bore a hole is polluted with the aseptic area that prevents the patient or damaged.

In further embodiment, disclose and be used for visual and control the each side of the demonstration of the ECG signal data that obtains via this catheter placement system.These demonstration aspects make the clinician can place described conduit or other intrusions intravital (invasive) armarium, with clearly with proximity (proximity) the relevant information of described equipment with respect to described ECG signal transmitting node.In another other embodiments, the many aspects of various ECG sensor constructions are also disclosed.

It is complete more clear that these and other features of embodiment of the present invention will become from following explanation and appending claims, perhaps can be by to being learned by the practice of hereinafter illustrated embodiment of the present invention.

Description of drawings

Will be by providing more concrete description of the present invention with reference to specific embodiment of the present invention, described specific embodiments is illustrated explanation in appended accompanying drawing.Be appreciated that these accompanying drawings only describe typical embodiments of the present invention, thereby can not be considered to limitation of the scope of the invention.To be described and explain exemplary of the present invention with additional feature and details by the operation instructions accompanying drawing, wherein:

Fig. 1 is according to an exemplary of the present invention, describes to be used for the block diagram of the various elements of the integrated system that the conduit in the vascular system places;

Fig. 2 is patient and the simplification view that is inserted into patient's conduit by means of the described integrated system of Fig. 1;

Fig. 3 A and 3B are the view of detector of the described integrated system of Fig. 1;

Fig. 4 for as be depicted in Fig. 1 as described in the screenshot capture of ultra sonic imaging on the display of integrated system;

Fig. 5 is used to the three-dimensional view of the probe that the described system with Fig. 1 uses when placing conduit in patient's vascular system;

Fig. 6 for as be depicted in Fig. 1 as described in icon (icon) on the display of integrated system, the position of indication distal end portion of the described probe of Fig. 5 in the put procedure of catheter tip;

Fig. 7 A-7E is depicted in the various exemplary icons on the described display of the described integrated system that can be depicted in Fig. 1 in the put procedure of catheter tip;

Fig. 8 A-8C is the screenshot capture of the image on the display of described integrated system that is depicted in Fig. 1 in the put procedure of catheter tip;

Fig. 9 is according to another exemplary of the present invention, describes the block diagram of the various elements of the integrated system that is used for the interior conduit placement of vascular system;

Figure 10 is patient and the simplification view that is inserted into patient's conduit by means of the described integrated system of Fig. 9;

Figure 11 is used to the three-dimensional view of the probe that the described integrated system with Fig. 9 uses when placing conduit in patient's vascular system;

Figure 12 A-12E is the various views of each several part of the described probe of Figure 11;

Figure 13 A-13D is the various views that are used for fin-shaped adapter (fin connector) assembly that the described integrated system with Fig. 9 uses;

Figure 13 E-13F is the various views that are used for cable (tether) adapter that uses with the described fin-shaped connector assembly shown in Figure 13 A-13D;

Figure 14 A-14C is the view that is connected that probe cable and the pick off of the described integrated system of fin-shaped adapter and Fig. 9 are shown;

Figure 15 is the cutaway view of the connection of the shown described probe cable of Figure 14 C, fin-shaped adapter and pick off;

Figure 16 is the simplification view of patient's ECG trace;

Figure 17 is the screenshot capture of the image on the display of described integrated system that is depicted in Fig. 9 in the put procedure of catheter tip;

Figure 18 is the cutaway view that comprises the fin-shaped adapter of the electrical contact that disposes according to an embodiment;

Figure 19 A and 19B are the simplification view that keeps (retention) system according to the electrical contact of the joint that is used for cable adapter and fin-shaped adapter of an embodiment;

Figure 20 A-20C is used for being used for setting up by sterile barrier the various views of an embodiment of the fin-shaped adapter of signal path and cable adapter in conjunction with making of described integrated system described herein;

Figure 21 A and 21B are the various views of adapter that are used for the ECG electrode is connected electrically to the pick off of described integrated system according to an embodiment;

Figure 22 A-22C is the various views that are used for setting up by sterile barrier an embodiment of the fin-shaped adapter of signal path and cable adapter;

Figure 23 A and 23B are the cutaway view that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 24 is the simplified side view that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 25 A and 25B are the simplified side view that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 26 A and 26B are the cutaway view that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 27 is the simplification view that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 28 is the three-dimensional view that is used for the probe that comprises aseptic protection body (shield) that uses with the connector system shown in Figure 28 according to an embodiment;

Figure 29 A and 29B are for according to the simplification view of ECG module of Figure 27 that is used for setting up by sterile barrier the connector system of signal path comprising of an embodiment;

Figure 30 is the simplification view that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 31 is the simplification view that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 32 is the simplification view of element that is used for setting up by sterile barrier the connector system of signal path according to an embodiment;

Figure 33 is the view that is used for setting up the device of conductive path between aseptic area and non-sterile zone according to an embodiment;

Figure 34 is the view that is used for setting up another device of conductive path between aseptic area and non-sterile zone according to an embodiment;

Figure 35 A-C depicted example P-wave-wave shape;

Figure 36 is for having the view of the pick off of wireless module according to being improved to of an embodiment;

Figure 37 is the retaining member view that is used for adapter according to an embodiment;

Figure 38 is the three-dimensional view according to the conduit that comprises the ECG pick off of an embodiment;

Figure 39 comprises a plurality of three-dimensional views that are arranged on the sensor cluster of supravasal electrode;

Figure 40 A-40C describes the operation of the conduit of Figure 39;

Figure 41 A-41D is the various views that connect integrity indicator and system according to the electrode of an embodiment;

Figure 42 is the three-dimensional view that connects integrity system according to the electrode of an embodiment;

Figure 43 A and 43B are the cutaway view according to the probe of an embodiment, and described probe comprises the conductor loop (wire loop) that is used for detector probe cut-out situation;

Figure 44 is that described probe comprises the conductor loop with flat lead according to the phantom of the probe of Figure 43 A of an embodiment;

Figure 45 is the cutaway view according to the conduit of an embodiment, and described conduit comprises having the probe that (interference) member is interfered in the distally;

Figure 46 is the cutaway view according to the conduit of another embodiment, and described conduit comprises the probe with distally interference member;

Figure 47 A and 47B are the cutaway view of distal part that is configured to keep the conduit of distal end portion alignment of conduit and probe and probe according to an embodiment;

Figure 48 is the three-dimensional view according to two ECG electrode assemblies of an embodiment;

Figure 49 is the three-dimensional view according to the outside ECG electrode assemblie that comprises figure of an embodiment;

Figure 50 is the ECG trace that the P-wave characteristic is shown according to an embodiment;

Figure 51 is for describing the flow chart according to a kind of method of an embodiment;

Figure 52-55 is the ECG trace according to the additional P-wave characteristic of illustrating of embodiment of the present disclosure;

Figure 56 A-57B is the ECG trace about the details of ECG waveform convergent-divergent of illustrating according to an embodiment;

Figure 58 is for describing the flow chart according to a kind of method of an embodiment;

Figure 59 is the display window of each side according to comprising of an embodiment of single ECG waveform;

Figure 60 is for describing the flow chart according to a kind of method of an embodiment;

Figure 61 places record for the conduit that is configured according to an embodiment; And

Figure 62 places record for another conduit that is configured according to an embodiment.

The specific embodiment

Referring now to accompanying drawing, wherein similar structure will be provided to similar Ref. No..Be appreciated that accompanying drawing is the sign of the diagrammatic of exemplary of the present invention and signal, and described accompanying drawing is nonrestrictive, also need not draw in proportion.

Fig. 1-62 describes the various features of embodiment of the present invention, and the present invention generally relates to the catheter placement system that is configured to place exactly conduit in patient's vascular system.In one embodiment, described catheter placement system adopts dual mode at least to improve the accuracy that conduit is placed: the ultrasonic aid in guide that 1) is used for conduit is imported patient's vascular system; And 2) terminal location/guidance system (" TLS "), or conduit by the progradation in crooked vascular system path in to the tracking based on the magnetic mode of catheter tip, in such progradation, to survey and convenient to any terminal correction that misplaces.According to an embodiment, the ultrasonic guidance of native system and terminal localized feature are integrated in the single equipment, make for the clinician to be used for placing conduit.This dual mode is integrated into has simplified the conduit put procedure in the single equipment, and obtains conduit modes of emplacement relatively faster.For example, described integrated catheter placement system makes ultrasonic and activity TLS can be observed from the single display of described integrated system.Moreover, the control device that is arranged on the ultrasonic detector (described detector is maintained at patient's aseptic area in the process that conduit is placed) of described integrated equipment can be used to control the function of described system, thus eliminate to the clinician outside the described aseptic area to control the needs of described system.

In another embodiment, the third mode, that is, guiding is included in the described system based on the catheter tip of ECG signal, to enable the desired locations with respect to the patient's who produces the ECG signal heart knot that guides to of catheter tip.This paper is also with so auxiliary being called of the arrangement based on ECG " terminal affirmation ".

According to an embodiment, the combination of above-mentioned these three kinds of modes can be placed described catheter placement system with the conduit of accuracy facility in patient's vascular system of a relative higher level, and promptly the distal end of conduit is in the placement of the position of predetermined and expectation.In addition, because the described guiding based on ECG of described catheter tip, the correction that the placement of end is carried out can need not the X ray of affirmation effect and be identified.This has reduced potential harm that the patient is subjected to X ray again, the patient is sent to X ray department and sends spent cost and time, costliness back to and the conduit of inconvenience is settled (reposition) process or the like again from X ray department.

Owing to comprise needs to following content based on the mode of ECG signal, promptly the conduit tube component in the aseptic area that is arranged on the patient is transferred to the data reception portion part of the system that is arranged in the non-sterile zone with the ECG signal, and embodiment of the present invention further relate to and being used for by making the isolating sterile barrier of described aseptic area and non-sterile zone set up the various connector systems of conductive path.Also disclose and be used for visual and control the each side that the described ECG signal data that obtains via native system shows, and the many aspects of various ECG sensor constructions.

For clarity sake, what will appreciate that is, the employed word of this paper " (proximal) of nearside " relates to more close clinician's direction relatively, and word " (distal) in distally " relates to relatively the direction further from the clinician.For example, the end that is placed on the intravital conduit of patient is considered to the distal end portion of described conduit, and described conduit still is retained in the proximal end that external end is described conduit.In addition, as the employed word of this paper (comprising claims) " comprise (including) ", " having (has) " and " having (having) ", should have the same word identical meaning that " comprises (comprising) ".

At first with reference to the Fig. 1 and 2 that describes according to the various parts of the catheter placement system (" system ") of exemplary configuration according to the present invention, described system usually is marked as 10.As directed, system 10 usually comprises control station 20, display 30, detector 40 and pick off 50, and wherein each all will be discussed in further detail below.

Fig. 2 illustrates relative patient 70, conduit 72 is put into the process of patient's vascular system, the universal relation of these parts inserting position 73 by skin.Fig. 2 illustrates conduit 72 and usually comprises the portions of proximal 74 of staying the patient outside and stay distal part 76 in patient's vascular system after placement is finished.System 10 is used to the distal end 76A of conduit 72 is finally settled (position) desired locations in patient's vascular system.In one embodiment, for conduit distal end 76A, described desired locations is the heart that closes on the patient, for example in following 1/3rd (1/3) parts of superior vena cava (" SVC ").Certainly, system 10 can be used to described conduit distal end is placed on other positions.Conduit portions of proximal 74 also comprises hub (hub) 74A, and hub 74A provides one or more inner chamber of conduit 72 to be communicated with one or more fluid that extends between the lower limb 74B that extends from described hub proximad.

The illustrative embodiments of control station 20 is shown among Fig. 8 C, yet what understand is, described control station can adopt a kind of in the various forms.The processor 22 that comprises nonvolatile memory (for example EEPROM) is included in the control station 20, is used for the function in the operating period of system 10 control system, thereby plays the effect of processor controls.With control station 20, also comprise digitial controller/modeling interface 24, and described digitial controller/modeling interface 24 is communicated by letter with the other system parts with processor 22 simultaneously, connects (interfacing) with control detector 40, pick off 50 and other system interface between parts.

System 10 also comprises and is used for the port 52 that is connected with pick off 50 and optional parts 54, comprises that printer, storage medium, keyboard wait for.Described in one embodiment port is a USB port, is connected with other interfaces described herein yet the combination of other port types or port type can be used to this port.With control station 20, include power supply connecting device 56, to enable and being operatively connected of external power supply device 58.Also can adopt internal cell 60 to use, or use internal cell 60 separately with external power supply device.Digitial controller/modeling interface 24 with described control station 20 includes electric power management circuit 59, to regulate using and distributing of power supply.

In the present embodiment, display 30 is integrated in the control station 20, and is used to show information to the clinician in the conduit put procedure.In another embodiment, described display can be isolating with described control station.As recognizing, change by the pattern (US, TLS or ECG in other embodiments are terminal to be confirmed) of display 30 described contents according to described catheter placement system place.In one embodiment, control station button interfaces 32 (seeing Fig. 1,8C) and the button that is included on the detector 40 can be used to directly call the pattern of (call up) expectation extremely to display 30, to play assosting effect in put procedure by described clinician.In one embodiment, for example in Figure 17, can be shown simultaneously from the information of various modes (for example TLS and ECG).Thereby, the ultrasonic guidance that the single display device 30 of system control position 20 carries out in the time of can being used in entering patient's vascular system, by the guiding of the TLS in the conduit progradation of vascular system, and (as in the embodiment after a while) affirmation based on ECG of placing with respect to the conduit distal end of patient's heart knot.In one embodiment, described display 30 is a LCD equipment.

Fig. 3 A and 3B describe the feature of detector 40 according to an embodiment.Detector 40 is used to use with described first mode above-mentioned, that is, visual based on ultrasonic (" US ") of vascular (for example, vein) prepared for conduit 72 inserts vascular systems.Being visualized as like this imports patient's vascular system with conduit provides real-time ultrasonic guidance, and helps to reduce the typical complication that is associated with such importing, comprises unexpected tremulous pulse perforation, hematoma, pneumothorax or the like.

Hand-held detector 40 comprises the head 80 that accommodates piezoelectric-array, when described head with the insertion position 73 (Fig. 2) of the contiguous expection of the mode that props up patient skin when being placed, described piezoelectric-array is used for producing ultrasonic pulse and admits echo by the described ultrasonic pulse behind patient's proprioceptive reflex.Detector 40 also comprises a plurality of control knobs 84 that can be included on the button panel (pad) 82.In the present embodiment, the mode of system 10 can be by control knob 84 controls, thereby, got rid of the needs of clinician outside the described aseptic area (inserting the position around the patient before conduit is placed forms), being used for the change pattern via making of control station button interfaces 32.

Like this, in one embodiment, the clinician adopts described first (US) mode to determine suitable insertion position and form vascular to enter, and for example utilizes pin or guiding device, utilizes conduit then.Then, described clinician can seamlessly switch to described second (TLS) mode via the button that pushes in the detector control panel with push-button 82, and need not outside the described aseptic area.Then, can use described TLS pattern to help conduit 72 advances towards the destination that is intended to by vascular system.

Fig. 1 illustrates detector 40 and also comprises button and storage control 42, is used for the operation of control knob and probe.In one embodiment, button and storage control 42 can comprise nonvolatile memory, for example EEPROM.Button is operationally communicated by letter with the prober interface 44 of control station 20 with storage control 42, prober interface 44 comprises and is used for the piezoelectricity I/O parts 44A that is connected with described detector piezoelectric-array interface, and is used for the button and the memorizer I/O parts 44B that are connected with storage control 42 interfaces with button.

Fig. 4 illustrates when system 10 during at its first ultrasonic power, as the exemplary screen shots of being described on display 30 88.The image 90 of patient 70 subcutaneous area is shown, describes the cross section of vein 92.Operation by the described piezoelectric-array of detector 40 generates image 90.Be included in equally on the indicator screen sectional drawing 88 is depth scale indicator 94, inner cavity size ratio 96 and other cue marks 98, depth scale indicator 94 provides about the information in the degree of depth of patient skin hypograph 90, inner cavity size ratio 96 provides the information about the size of the vein 92 of relative standard conduit cavity size, other cue marks 98 provide the information of the action that maybe may take about the state of system 10, for example, fix picture, image template, preservation data, image print, power supply status, brightness of image or the like.

Note that in other embodiments when vein was depicted in the image 90, other chamber body or part can be by imagings.What notice is if desired, can be depicted in together on the display 30 with other patterns (for example, described TLS pattern) simultaneously in the described US pattern shown in Fig. 4.Between resting period, except that visual display 30, system 10 can also adopt auditory information (for example, beeping sound, tone or the like) to come assist clinicians at conduit.In addition, the described button and the control station button interfaces 32 that are included on the detector 40 can dispose in every way, comprise using for example user input control device of slide switch, change-over switch, electronics or touch-control sensing formula plate or the like except button.Additionally, between the operating period of system 10, the two activity of US and TLS can take place simultaneously or take place separately.

As just described, hand-held ultrasound detector 40 is used as the part of integrated catheter placement system 10, and is visual with the US that enables the patient's vascular system periphery, for the percutaneous importing of conduit is prepared.Yet as described below in this exemplary, when guiding described conduit in vascular system when the destination of its expectation advances, described detector also is used to the described TLS part of control system 10 or the function of second mode.Moreover because detector 40 is used in described patient's the described aseptic area, this feature makes it possible to fully from described aseptic area the function to TLS and controls.Thereby detector 40 is the equipment of double duty, enables from described aseptic area the US of system 10 and the convenient control of TLS function.In one embodiment, as will be further described below, described detector can also be used to control some or all functions of Third Way relevant with ECG or catheter placement system 10.

Catheter placement system 10 also comprises described second mode above-mentioned, that is, and and based on the conduit TLS or the terminal navigation system of magnetic mode.In the propulsive process of vascular system of initially putting into and pass through patient 70, described TLS makes the clinician can locate and confirm the position and/or the orientation of conduit 72 fast, and described conduit 72 for example is peripheral vein puncture central venous catheter (" PICC "), central venous catheter (" CVC ") or other conduits that is fit to.Particularly, described TLS mode detects the magnetic field that is excited by the terminal position probe that is equipped with magnetic cell, in one embodiment, described terminal position probe is preloaded with in the inner chamber of the conduit 72 that is limited in vertical mode, thereby makes described clinician can determine the general location and the orientation of described catheter tip in patient's body.In one embodiment, can use one or more the kind instructions in the following United States Patent (USP) that described magnetic assembly is followed the trail of: 5,775,332; 5,879,297; 6,129,668; 6,216,028 and 6,263,230.This paper incorporates the full content of above-mentioned United States Patent (USP) into the application by reference.Described TLS also shows the direction that described catheter tip is pointed, thus the further accurate placement of subsidiary conduit.The further assist clinicians of described TLS determines when the dislocation of described catheter tip takes place, and has for example departed from desired vein path when entering another venous situation at described end.

As mentioned, described TLS utilizes the described distal end portion that probe makes conduit 72 can be tracked in by the progradation of vascular system at it.Fig. 5 has provided an embodiment of such probe 100, and probe 100 comprises proximal end 100A and distal end portion 100B.100A includes handle in the probe proximal end, and the heart yearn 104 that distad extends from described handle.The magnetic assembly is set at heart yearn 104 distally.Described magnetic assembly comprises that one or more contiguous probe distal end portion 100B is by setting adjacent one another are and by the magnetic cell 106 of managing 108 encapsulation.In the present embodiment, include a plurality of magnetic cells 106, each element comprises the solid circles column ferromagnet that piles up in end-to-end mode with other magnetic cells.Binding agent end 110 can be in the described distal end of magnetic cell 106 distally plug plugging 108.

What please note is that in other embodiments, described magnetic cell also can change in the design of composition, number, size, magnetic type and the aspects such as position in described probe distal section not only at vpg connection.For example, in one embodiment, described a plurality of ferromagnetic elements are substituted by electromagnetic assembly, for example produce the solenoid that is used for by the magnetic field of described sensor.Another embodiment at this available assembly obtains in the U.S. Patent No. 5,099,845 of " medical apparatus and instruments positioner (Medical Instrument Location Means) ", and this paper incorporates its full content into the application by reference.In addition, comprise exercise question that other embodiment of the probe of the magnetic cell that can use with described TSL mode can submit on August 23rd, 2006 U. S. application No.11/466 for " probe instrument and manufacture method (Stylet Apparatuses and Methods of Manufacture) ", obtain in 602, this paper incorporates its full content into the application by reference.Therefore, embodiment of the present invention intention comprises these and other variants.Should be understood that at this as used herein " probe (stylet) " can comprise and be configured to place removably to help distal end portion with described conduit to be placed in the various device of desired locations in the patient's vascular system any in the inner chamber of described conduit.

Fig. 2 illustrates the situation that is provided with of probe 100, and probe 100 is basically in the inner chamber of conduit 72, so that the described portions of proximal of probe 100 extends from described conduit cavity proximad, stretches out by hub 74A and by extending selected among the lower limb 74B one.Be arranged on like this in the described conduit cavity, the distal end portion 100B of probe 100 and distal catheter end 76A are common termination basically, so that are indicated the position of described conduit distal end portion by the corresponding detection that described TLS carried out of described probe distal end portion.

In TLS operating period, the magnetic field that system 10 adopts TLS pick offs 50 to produce with the magnetic cell 106 that detects by probe 100.As shown in Figure 2, during conduit inserted, TLS pick off 50 was placed on patient's chest.TlS pick off 50 is placed on the predetermined position (as by using outer body sign (landmark)) of patient's chest, to enable the magnetic field that is set at the probe magnetic cell 106 in the conduit 72 as described above, it is detected during the current process of conduit patient vascular system.Moreover, because the distal end portion 76A (Fig. 2) of the magnetic cell of probe magnetic assembly 106 and conduit 72 is common terminations, the detection in the magnetic field of the described magnetic cell that is undertaken by TLS pick off 50 provides about position and the directed information of described conduit distal end portion during it is current to the clinician.

More specifically, as shown in Figure 1, TLS pick off 50 is operably connected to the control station 20 of system 10 via in the port 52 one or more.What please note is, can also use other connectivity scenarios and unrestricted between described TLS pick off and described system control position.As described, magnetic cell 106 is used in the probe 100 so that conduit distal end portion 76A (Fig. 2) is placed on the position of TLS pick off 50 of patient's chest relatively can be observable.During the TLS pattern, the detection of the probe magnetic cell 106 that is undertaken by TLS pick off 50 is displayed on the display 30 of control station 20 in patterned mode.By this way, the clinician who places described conduit can determine the position of the relative TLS pick off 50 of conduit distal end portion 76A in patient's vascular system substantially, and when detected catheter dislocation (for example, described conduit is along the propelling that vein carried out of non-expectation) takes place.

Fig. 6 and 7A-7E illustrate the embodiment of icon, and described icon can use the probe magnetic cell 106 to describe to be undertaken by TLS pick off 50 to detect by controlled display 30.Distinguishingly, Fig. 6 illustrates when described magnetic cell is positioned in described TLS pick off below, describes the icon 114 of the described distal part (comprising the magnetic cell 106 that is detected as by TLS pick off 50) of probe 100.Because the distal end portion 76A of probe distal end portion 100B and conduit 72 is common termination basically, described icon is indicated the position and the orientation of described conduit distal end portion.Fig. 7 A-7E illustrate magnetic cell 106 when probe 100 be not positioned in TLS pick off 50 under when (but near still being detected), can be depicted in the various icons on the console display 30.Described icon can comprise according to the position of described probe magnetic assembly (that is, in the present embodiment, the position of magnetic cell 106 relative TLS pick offs 50) and the

half icon

114A and 1/4th icon 114B that are shown.

Fig. 8 A-8C is depicted in the screenshot capture of the display 30 of taking from system 10 in the TLS pattern, and how the described magnetic assembly that probe 100 is shown is described.The screenshot capture 118 of Fig. 8 A illustrates the sign image 120 of TLS pick off 50.Other information on the indicator screen sectional drawing 118 of being provided at comprise depth scale indicator 124, state/action cue mark 126 and with the corresponding icon 128 of button interfaces 32 (Fig. 8 C) that is included on the control station 20.Although in the present embodiment, icon 128 is simple indicator purposes with guiding user identification button interfaces 32 corresponding buttons, in another embodiment, described display can be made into the touch-control sensing formula, thereby described icon self can play the effect of button interfaces and can change according to the pattern at described system place.

Inserting the patient's vascular system rear tube by during the propulsive starting stage of vascular system, the distal end portion 76A that has the conduit 72 of common termination with probe distal end portion 100B basically is relative far away apart from TLS pick off 50.Like this, described indicator screen sectional drawing will be pointed out " no signal ", and indication is not detected from the magnetic field of described probe magnetic assembly.In Fig. 8 B, the described magnetic assembly of contiguous probe distal end portion 100B although it not under described pick off, has been advanced to enough can be detected near TLS pick off 50.This half icon 114A by the left side that is illustrated in sensor image 120 is indicated, and the magnetic assembly that characterizes described probe is the right side that is positioned in TLS pick off 50 from patient's visual angle.

In Fig. 8 C, the described magnetic assembly of contiguous probe distal end portion 100B advances below TLS pick off 50, so that its relative position and directional energy are arrived by described TLS sensor.This is by 114 indications of the icon on sensor image 120.What please note is that button icon 128 provides can be by pushing the prompting of the action that corresponding buttons realizes in the control station button interfaces 32.Like this, button icon 128 can change according to the mode at system 10 places, thereby provides motility in the use for button interfaces 32.What please further note is, because the control panel with push-button 82 of detector 40 (Fig. 3 A, 3B) comprises the button 84 that can imitate a plurality of buttons in the button interfaces 32, in in remaining in described aseptic area, the button icon 128 on the display 30 provides guiding to utilize detector button 84 control system 10 to the clinician.For example, if the clinician need leave the TLS pattern and return US (ultrasonic) pattern, suitable control knob 84 in detector control panel with push-button 82 can be pressed, and described US pattern can be called immediately, display 30 flushes to and adapts to the required described visual information of US function simultaneously, as shown in Figure 4.This need not the clinician and can realize outside described aseptic area.

With reference now to Fig. 9 and 10,, integrated catheter placement system 10 is described according to another exemplary.The same, as described above, integrated system 10 comprises control station 20, display 30, is used for the detector 40 of US function, and the TLS pick off 50 that is used for terminal positioning function.What please note is that the system of being described among Fig. 9 and 10 10 is similar in all many-sides to the system shown in Fig. 1 and 2.Thus, only the difference of selecting is discussed below.Fig. 9 and 10 system 10 comprise additional function, wherein other electric pulses of relative antrum of conduit distal end 76A (" SA ") or patient's 70 heart send the determining and can be identified of nearness of knot, thereby provide enhanced ability to come exactly described conduit distal end to be placed on the desired locations of contiguous described knot.In addition, this paper is referred to as " ECG " or " end based on ECG is confirmed ", and this Third Way of system 10 enables the detection from the ECG signal of described SA knot, so that described conduit distal end is placed on desired locations in described patient's vascular system.What please note is that described US, TLS and ECG mode are seamlessly made up in native system 10, but can together be used or use separately and help place conduit.In one embodiment, should be understood that the ECG mode can be included in does not as described herein comprise US and TLS mode in independence (stand-alone) system.Therefore, the residing environment of embodiment described herein is understood that it only is exemplary environment and can not being considered to restriction of the present disclosure.

Fig. 9 and 10 illustrates the system 10 that is configured with probe 130 according to the present embodiment in addition.As a complete unit, catheter probe 130 is set in advance removably in the described inner chamber of the conduit 72 that is inserted into patient 70 via insertion position 73.Probe 130, except comprising the magnetic assembly that is used for based on the TLS mode of magnetic mode, comprise the sensing element (being the ECG sensor cluster) of contiguous its distal end portion, and comprise a part that is total to the termination with the described distal end portion of described catheter tip, be used to survey the ECG signal that produces by described SA knot.With previous embodiment by contrast, probe 130 comprises the cable 134 that extends from its proximal end, cable 134 is operably connected to TLS pick off 50.As will further being described with details, in the affirmation process of the described end of picc of a part of confirming mode as described end based on the ECG signal, probe cable 134 allows to be sent to TLS pick off 50 by the detected ECG signal of described ECG sensor cluster on the distal part that is included in probe 130.Reference and ground connection ECG core/electrode pair 158 are attached to patient 70 body, and operationally be attached to TLS pick off 50 so that can described system filter the irrelevant high level electrical activity of electrical activity with the SA knot of heart, confirmed function thereby enable described end based on ECG.Be received from the reference signal and the ground signalling of the ECG core/electrode pair 158 that is placed on the patient skin, be positioned in the TLS pick off 50 (Figure 10) of patient's chest or other specified parts receptions of system 10 with the described ECG signal of surveying by described probe ECG sensor cluster.As will be described, TLS pick off 50 and/or control station processor 22 can be handled described ECG signal data to produce electrocardiographic wave on display 30.Handle under the situation of described ECG signal data at TLS pick off 50, processor is included in wherein to realize the function of intention.If control station 20 is handled described ECG signal data, processor 22, controller 24 or other processors can be employed in described control station, with processing said data.

Therefore, as described above along with it advances past patient's vascular system, the conduit 72 that is equipped with probe 130 can advance down at the TLS pick off 50 (as shown in figure 10) that is placed on patient's the chest.This makes the position of the described magnetic assembly that TLS pick off 50 can detector probe 130, and the described magnetic assembly of probe 130 and the distal end 76A that is positioned at the described conduit in the patient's vascular system are common termination basically.During the ECG pattern, the detection of the described probe magnetic assembly that is undertaken by TLS pick off 50 is depicted on the display 30.During the ECG pattern, display 30 is also described the ECG electrocardiographic wave that the result produced by the detected patient's heart electrical activity of described ECG sensor cluster of probe 130.More specifically, comprise that the described ECG electrical activity of the described SA knot of P-wave-wave shape is detected by the described ECG sensor cluster (describing below) of described probe, and be transferred into TLS pick off 50 and control station 20.Then, described ECG electrical activity is processed to be described on display 30.Subsequently, the clinician who places described conduit can observe the best of the distal end 76A that described ECG data determine conduit 72 and place, and for example is contiguous described SA knot in one embodiment.In one embodiment, control station 20 comprises the necessary electronic parts (for example processor 22 (Fig. 9)) that receive and handle the described signal that is detected by described probe ECG sensor cluster.In another embodiment, TLS pick off 50 can comprise the necessary electronic parts of handling described ECG signal.

As already discussed, in the put procedure of described conduit, display 30 is used to show information to the clinician.The content of display 30 changes according to the pattern (US, TLS or ECG) at described catheter placement system place.The clinician can call in these three kinds of patterns any immediately to display 30, and in some cases, can be shown simultaneously from the information of various modes (for example TLS and ECG).In one embodiment, as before, the pattern at described system place can be by control knob 84 control that is included on the hand-held detector 40, thus got rid of the clinician outside the described aseptic area (for example, the button interfaces 32 of touch-control control station 20) to change the needs of pattern.Thereby in the present embodiment, detector 40 also is used to some or all functions relevant with ECG of control system 10.What please note is that button interfaces 32 or other input structures also can be used to the control system function.Equally, between resting period, except using visual display 30, described system can also adopt auditory information (for example, beeping sound, tone or the like) to come assist clinicians at conduit.

With reference now to Figure 11-12E,, describe the various details of an embodiment of probe 130, probe 130 is loaded into the distal end 76A that is used in the conduit 72 and during inserting described conduit removably and is placed in desired locations in patient's vascular system.Go out as shown, when when described conduit shifts out, probe 130 limits proximal end 130A and distal end portion 130B.Adapter 132 is included in nearside sound end 130A, and cable 134 distad extends and is attached to handle 136 from described adapter.Heart yearn 138 distad extends from handle 136.In one embodiment, probe 130 is preloaded with in the inner chamber of conduit 72, so that distal end portion 130B flushes with described catheter opening basically at described conduit distal end portion 76A place (Figure 10) or termination altogether, and a so that proximad extension selecting from extension 74B of portions of proximal, handle 136 and the cable 134 of heart yearn 138.What notice is that although this paper is described with probe, in other embodiments, seal wire or other catheter guidance apparatuses can be included in the principle of embodiment described herein.

Heart yearn 138 limits elongated shape and is to be made of the probe material that is fit to, and comprises rustless steel or memory material, for example the alloy that comprises nickel and titanium in one embodiment (the generally well-known Nitinol (" nitinol ") of being abbreviated as).Although do not illustrate in this article, in one embodiment, heart yearn 138 makes the corresponding described part of distal section of described heart yearn and described probe can have preformed warp architecture by Nitinol manufacturing, thereby impels the described distal part of conduit 72 to form similar warp architecture.In other embodiments, described heart yearn does not comprise preform.Further, described Nitinol structure strengthens the torsion capacity of heart yearn 138, so that the distal section of probe 130 can be controlled when in the described inner chamber that is set at conduit 72, this makes the described distal part of described conduit can be guided through vascular system again during conduit inserts.

Provide handle 136 to enable described probe to the insertion of conduit 72/remove.At probe heart yearn 138 is in the coilable embodiment, and handle 136 further makes described heart yearn can be rotated in the described inner chamber of conduit 72, to help the vascular system of the described conduit distal part of guiding by patient 70.

Handle 136 is attached to the distal end portion of cable 134.In the present embodiment, cable 134 is the cables that have elasticity, shielded, and cable 134 contains the one or more leads that are connected electrically to heart yearn 138 (playing the effect of top related described ECG sensor cluster) and cable adapter 132.Like this, cable 134 provides from the described distal part of heart yearn 138 and passes through the conductive path of cable adapter 132 to the proximal end 130A of probe 130.As will be explained, cable adapter 132 is configured to be operably connected to the TLS pick off 50 on patient's chest, with helping that conduit distal end 76A is directed to desired locations in patient's vascular system.

As being seen at Figure 12 B-12D, the distal part of heart yearn 138 142 distad is tapered or reduces at diameter from the abutment.Sleeve pipe 140 slides on the heart yearn part of described minimizing diameter.Although have relatively large diameter at this, in another embodiment, described sleeve pipe can selected size mate the diameter of the described portions of proximal of described probe heart yearn basically.Probe 130 also comprises the magnetic assembly that is used by contiguous its distal end portion 130B being used for of being provided with during the TLS pattern.In the described embodiment that illustrates, described magnetic assembly comprises a plurality of magnetic cells 144 between the inner surface of the outer surface that is set at the heart yearn 138 that reduces diameter and sleeve pipe 140 contiguous probe distal end portion 130B.In the present embodiment, magnetic assembly 144 comprises the ferromagnet that the mode with the probe 100 that is similar to Fig. 2 of 20 solid circles columns is piled up end-to-end.Yet in other embodiments, described magnetic cell can be not only at vpg connection, and also can change in the design of composition, number, size, magnetic type and the aspects such as position in described probe.For example, in one embodiment, described a plurality of magnets of described magnetic assembly are used for being substituted by the solenoid in the magnetic field of described TLS sensor by generation.Therefore, embodiment of the present invention intention comprises these and other variants.

Magnetic cell 144 is used in the distal part of probe 130 so that probe distal end portion 130B is placed on the position of the TLS pick off 50 on patient's chest relatively can be observable.As already mentioned, along with the conduit 72 with described probe advances past patient's vascular system, TLS pick off 50 is configured to detect the magnetic field of magnetic cell 144.By this way, the clinician who places conduit 72 can determine substantially when position and the detected catheter dislocation (for example, described conduit along the venous of non-expectation advance) of conduit distal end portion 76A in patient's vascular system takes place.

According to an embodiment, probe 130 also comprises above-mentioned ECG sensor cluster.During inserting, described ECG sensor cluster makes the probe 130 in the inner chamber that is arranged on conduit 72 can be used to detect ECG signal in the atrium that is produced by SA or other patient's hearts knot, allows the distal end 76A of conduit 72 is directed to the predetermined position of contiguous patient's heart in vascular system thus.Therefore, described ECG sensor cluster helps out in the suitable placement location of confirming conduit distal end 76A.

In the embodiment of explanation, described ECG sensor cluster comprises the distal part of the heart yearn 138 that contiguous probe distal end portion 130B is provided with illustrated in Figure 11-12E.Heart yearn 138 has electric conductivity, and the ECG signal can and can be transmitted along described heart yearn proximad by its described distal end portion detection.Conductive material 146 (for example, conductive epoxy) is filled sleeve pipe 140 distal part of the described distal terminus of contiguous heart yearn 138, thereby is communicated with electrically conducting manner with the described distal end portion of described heart yearn.This has increased the described conductive surface of the distal end portion 130B of probe 130 again, detects the ability of ECG signal thereby improved it.

Before placing conduit, probe 130 is loaded in the inner chamber of conduit 72.What please note is, can probe 130 be pre-loaded into described conduit cavity by manufacturer, or before inserting conduit by clinician's described conduit of packing into.Probe 130 is placed in the described conduit cavity, so that the distal end 76A of the distal end portion 130B of probe 130 and conduit 72 is common termination basically, thereby makes the placement that is in alignment with each other basically of the two described distal end of described probe and described conduit.As has already been described, the described termination altogether of conduit 72 and probe 130 makes described magnetic assembly play such effect with TLS pick off 50 in the TLS pattern, i.e. its position is followed the trail of in the propelling of being carried out in patient's vascular system along with conduit distal end 76A.Yet what please note is that with regard to the described terminal affirmation function of system 10, the distal end portion 130B of probe 130 need not to be total to the termination with conduit distal end portion 76A.On the contrary, the conductive path that required only is between vascular system and described ECG sensor cluster be exactly heart yearn 138 in this case, so that the electric pulse of described SA knot or other patient's hearts knot can be detected.In one embodiment, this conductive path can comprise various compositions, comprises saline solution, blood or the like.

In one embodiment, in case conduit 72 is imported into patient's vascular system via inserting position 73 (Figure 10), can adopt the propulsion bulb distal end 76A of destination that is intended to of the contiguous described SA knot of described TLS pattern conductive pipe tomorrow distal end 76A of system 10 as has already been described.Near behind the heart area, system 10 can be switched to the ECG pattern so that the ECG signal of being binded up one's hair out by described SA can be detected.Along with the described conduit that probe is housed is pushed into towards patient's heart, comprise that the described distal end portion of heart yearn 138 and the described electric conductivity ECG sensor cluster of conductive material 146 begin to detect the electric pulse that is produced by described SA knot.Like this, described ECG sensor cluster plays the effect of the electrode that detects described ECG signal.The elongated heart yearn 138 of contiguous described heart yearn distal end portion as conductive path with produced by described SA knot and be sent to cable 134 by the received electric pulse of described ECG sensor cluster.

Cable 134 is delivered to described ECG signal the TLS pick off 50 that temporarily is placed on patient's chest.Cable 134 operationally is connected to TLS pick off 50 via cable adapter 132 or other direct or indirect structures that plays interconnect function that is fit to.As described, described then ECG signal can be processed and be depicted in (Fig. 9,10) on the system display 30.To the monitoring that the described ECG signal that is received by TLS pick off 50 and shown by display 30 carries out, make the clinician observe and to analyze the variation that in described signal, takes place along with the propelling of conduit distal end 76A towards described SA knot.When the profile (profile) of received ECG Signal Matching one expectation, the clinician can determine that conduit distal end 76A has arrived a desired locations with respect to described SA knot.As mentioned, in one embodiment, this desired locations is positioned at following 1/3rd (1/3) parts of described SVC.

Described ECG sensor cluster and magnetic assembly can cooperate assist clinicians to place conduit in vascular system.Usually, the described magnetic assembly of probe 130 is assist clinicians total vascular system guiding of inserting beginning from initial conduit, is placed on the distal end portion 76A with conduit 72 in total zone of patient's heart.Then, along with described probe ECG sensor cluster is tied near described SA, by the variation that is taken place in the described ECG signal that the clinician can be observed produced by heart, described ECG sensor cluster can be used in described SVC conduit distal end portion 76A be guided to desired locations.Have, in case observe suitable ECG signal profile, the clinician can determine that the two distal end portion of probe 130 and conduit 72 has arrived at the described desired locations with respect to patient's heart again.In case conduit 72 has been placed as expected, conduit 72 can be fixed on the appropriate location, and probe 130 removes from described conduit cavity.At this, what please note is, described probe can comprise except that this paper clearly described various structures in a kind of.In one embodiment, described probe can directly be attached to described control station rather than be carried out attached via described TLS pick off indirectly.In another embodiment, the structure that enables the probe 130 of its TLS and the function relevant with ECG can be integrated in the described guide-tube structure self.For example, in one embodiment, described magnetic assembly and/or ECG sensor cluster can be merged in the wall of described conduit.

Figure 13 A-15 describes about the various details from probe cable 134 to the ECG signal data path that is positioned in the TLS pick off 50 on patient's chest according to the present embodiment.Particularly, this embodiment relates to the path (comprising probe 130 and cable 134) from the ECG signal data of the aseptic area that centers on conduit 72 and insertion position 73, and non-sterile zone, for example is placed patient's chest of described TLS pick off on it.Such path should not can destroy described aseptic area and makes its aseptic undermined.Be positioned in the major part that sterile sheet on the patient 70 limits described aseptic area in the insertion process of described conduit: the zone on described cloth list is aseptic, and thereunder (do not comprise described insertion position and tightly region surrounded) is non-sterile.As with visible, below the discussion carried out comprise be associated with probe 130 at least one first be communicated with node, and be associated with TLS pick off 50 second be communicated with node, operationally connect each other so that the ECG signal data can be in the two transmission.

What described among Figure 13 A-15 is a such embodiment, promptly solve the path problem that does not influence the ECG signal data of the former aseptic from described aseptic area to described non-sterile zone, describe the embodiment of " passing cloth list (through-drape) ", be also referred to as the implementation of " shark fins (shark fin) ".Particularly, as described above, Figure 14 A is illustrated in the TLS pick off 50 that is used to be placed in the insertion process of conduit on patient's chest.TLS pick off 50 is included in the adapter bottom 152 of the qualification groove 152A of its top surface, is provided with three electric bottom contact 154 in groove 152A.Same in the 156 selected sizes of the fin-shaped adapter shown in Figure 13 A-13D, the groove 152A that the next mode to slide shown in Figure 14 B and 15 is connected device bottom 152 is admitted.Two ECG core/electrode pairs 158 extend from fin-shaped adapter 156, are used to be placed on other external positions that are fit on shoulder and trunk or the patient's body.Cloth list-pass the part that cable adapter 132 is configured to connect in the mode of sliding fin-shaped adapter 156, to realize passing through the conductive path of described aseptic area from probe 120 as will be described further below to TLS pick off 50.

Figure 13 A-13D illustrates other each side of fin-shaped adapter 156.Particularly, fin-shaped adapter 156 limits the following cylindrical portion 160 that selected size is connected the groove 152A admittance (Figure 14 B, 15) of device bottom 152.The hole 162 that is centered on by the center conical surface 164 is included on the rear end of cylindrical portion 166.Last cylindrical portion 166 selected sizes are admitted the cable adapter 132 (Figure 14 C, 15) of probe 130, so that the pin contact 170 that extends into the groove 172 (Figure 15) of cable adapter 132 is guided by described centre bore, be located in the hole 162 of fin-shaped adapter 156 up to it, thereby make described cable adapter and described fin-shaped adapter interconnection.Fastener (as at the fastener shown in Figure 13 C and the 13D 169) can be included on the either side of fin-shaped adapter 156, to engage, help remain on connect (mating) between these two parts with corresponding retainer (detent) 173 (Figure 13 F) on cable adapter 132.If the disengaging between these two parts is expected, holding with a firm grip or fixedly applying enough revolution pulling force to cable adapter 132 in the fin-shaped adapter 156, remove from the groove 152A of adapter bottom 152 to prevent fin-shaped adapter 156.

Figure 13 D illustrates fin-shaped adapter 156 and comprises a plurality of electrical contacts 168.In the present embodiment, three contacts 168 are comprised with such form: each of two top contacts is electrically connected one terminal in the ECG core 158, and the contact of back extends into the axial adjacent domain of hand-hole 162, thereby when the pin contact 170 of cable adapter 132 connects fin-shaped adapter 156 (Figure 15), be electrically connected the pin contact 170 of cable adapter 132.The bottom branch of each contact 168 of fin-shaped adapter 156 is placed in the bottom contact 154 that is electrically connected TLS sensor connector bottom 152 corresponding one.In one embodiment, the bottom branch of each contact 168 comprises retaining member, for example recessed (indentation) 168A.So configuration is consequently when fin-shaped adapter 156 is received by TLS sensor connector bottom 152, each contact 168 can pliable and tough ground engage base contact 154 in separately one, thereby the end of each bottom contact is received among separately the recessed 168A.Such configuration provides additional fixing (Figure 15) to help prevent that fin-shaped adapter 156 from separating ahead of time from adapter bottom 152.Outside being noted that this paper illustrated and described, between bottom contact 154 and fin-shaped contact 168, can also comprise many different retaining members.

Figure 13 E and 13F describe the various details of cable adapter 132 according to an embodiment, the retainer 173 that comprises cable adapter groove 172 as described above, is arranged on the pin contact 170 in the described groove and is used for engaging removably the fastener 169 of fin-shaped adapter 156 (Figure 13 A-13D).Figure 13 E also illustrates grasping (gripping) part 171 of the embodiment of the structure that a plurality of conducts can be included to help the clinician to hold cable adapter 132 with a firm grip.

Figure 14 B illustrates and is used for interconnected first access phase of parts described above, wherein, make fin-shaped adapter 156 connect TLS sensor connector bottom 152 removably by the following cylindrical portion 160 of described fin-shaped adapter and being slidably engaged of adapter bottom groove 152A.This joint makes adapter bottom contact 154 and corresponding fin-shaped contact 168 be electrically connected (Figure 15).

Figure 14 C illustrates second access phase, wherein by being slidably engaged between the last cylindrical portion 166 of cable adapter groove 172 and described fin-shaped adapter, makes cable adapter 132 connect fin-shaped adapter 156 removably.As best visible in Figure 15, this joint is electrically connected the back contact 168 of cable connector pin contact 170 and fin-shaped adapter 156.In the present embodiment, cable adapter 132 is with respect to the horizontal slip campaign of fin-shaped adapter 156 on identical direction of engagement with the sliding motion of (Figure 14 B) when described fin-shaped adapter slidably is coupled to described sensor connector bottom groove 152A.In one embodiment, one or two in the probe 130/ cable adapter 132 and fin-shaped adapter 156 are disposable.Equally, in one embodiment, described cable adapter is after described fin-shaped adapter has been mated into described TLS pick off, can be mated into described fin-shaped adapter, and in another embodiment, described cable adapter can be mated into described fin-shaped adapter by surgical operation cloth list earlier before described fin-shaped adapter is mated into described TLS pick off.

In the connectivity scenario shown in Figure 14 C, probe 130 is operably connected to TLS pick off 150 via cable adapter 132, thereby makes the described ECG sensor cluster of described probe the ECG signal can be sent to described TLS pick off.In addition, ECG core/electrode pair 158 is operably connected to TLS pick off 50.Yet in one embodiment, cable adapter 132 is called as the first connection node that is used for probe 130, and fin-shaped adapter 156 is called as the second connection node that is used for TLS pick off 50.As will be seen, can utilize various other first and second be communicated with the foundation that nodes enable the conductive path between described ECG sensor cluster and described TLS pick off or the other system parts.

What please note is that various scheme and structures that other play interconnect function can be used to realize exercisable connection between described probe and described TLS pick off.For example, described cable adapter can use sheet contact rather than pin contact to pierce through described cloth list.Perhaps, described fin-shaped adapter can form with described TLS pick off.Therefore, these and other structures are comprised in the scope of embodiment of the present invention.

As mentioned, cloth list 174 is placed on the patient 70 usually, and be used as barrier with on all lists of cloth as described and the patient's of contiguous zone of inserting position 73 and parts (comprising conduit 72, probe 130 and cable 134 (Figure 10)) aseptic area, the zone under all lists of cloth as described and parts (comprise the patient chest, be placed on the chest pick off 50 (Figure 10) and this be also referred to as be non-aseptic area tightly around patient 70 zone) described aseptic area outside non-sterile zone separate.As seen in fig. 15, be placed between the interconnecting of cable adapter 132 and fin-shaped adapter 156 at the sterile sheet 174 that is used to form aseptic area between the resting period of conduit.As described, cable adapter 132 comprises the pin contact 170 that is configured to pierce through cloth list 174 when described two parts are matched.Such thorn is through in the sterile sheet 174 that is occupied by pin contact 170 and forms duck eye or bore a hole 175, thus the minimized in size of the described cloth single column that will form by described pin contact.In addition, cooperation between cable adapter 132 and the fin-shaped adapter 156 is such, so that the described perforation that is formed by passing of pin contact 170 in sterile sheet is surrounded by cable adapter groove 172, thereby keeps the described aseptic of described cloth list and prevent that the breach in the described cloth list from may damage the described aseptic area that forms thus.Cable adapter groove 172 is shaped like this and is disposed, before being pierced through, sterile sheet 174 is rolled over downwards by pin contact 170, so that described pin contact can not pierce through described cloth list before the hole 162 that is set to contiguous fin-shaped adapter 156, and so that described cloth singly can pleating (bunch up) in described groove.At this, what please note is, cable adapter 132 and fin-shaped adapter 156 are disposed like this, aim at by (blindly) in sightless mode of opaque sterile sheet 174 therebetween with facility, that is, via the clinician under sightless situation to two touch inspections that parts carried out.

As already mentioned, what please further note is, the fin-shaped contact 168 of fin-shaped adapter 156 as shown in Figure 15 comprises the recessed 168A that is configured to connect by this way sensor base contact 154, i.e. the described fin-shaped adapter of help maintenance engages with sensor base groove 152A's.This reduces again fin-shaped adapter 156 being fixed to the demand of the additional apparatus of TLS pick off 50.In other embodiments, can be with the isolating retaining member of described electrical contact with helping keep engaging of described fin-shaped adapter and described sensor base groove.In one embodiment, bottom contact 154 can be configured to spring needle (pogo pins), thus bottom contact for vertically movably (displaceable) to help to keep fin-shaped adapter 156.

Figure 16 illustrates the patient's who comprises P-ripple and QRS wave group typical ECG waveform 176.And for native system 10, usually, the amplitude of described P-ripple changes according to the distance of described ECG sensor cluster from the described SA knot of the P-ripple that produces waveform 176.When the clinician can be close to this relation of using when heart is settled rightly at definite described catheter tip.For example, in one embodiment, as already discussed, described catheter tip is placed in described superior vena caval following 1/3rd (1/3) in the mode of expectation.The described ECG data that detected by the described ECG sensor cluster of probe 130 are used to reproduce waveform (for example, waveform 176), are used for being described on the display 30 in system 10 during the ECG pattern.

With reference now to Figure 17,,, the each side of shown ECG signal data on display 30 is described when system 10 is in ECG pattern (the described Third Way that will be further described below) according to an embodiment.The screenshot capture 178 of display 30 comprises a plurality of key elements of described TLS mode, the token image 120 that comprises TLS pick off 50, described token image 120 have current pass patient's vascular system during corresponding to the icon 114 of the position of the described distal end portion of probe 130.Screenshot capture 178 also comprises window 180, and the current ECG waveform of being caught and being handled by system 10 by the described ECG sensor cluster of probe 130 is displayed in the window 180.Along with new waveform is detected, window 180 constantly is refreshed.

Window 182 comprises describing continuously that the up-to-date ECG waveform that is detected is carried out, and comprises and refresh bar 182A, along with described waveform is detected, refreshes bar 182A and laterally moves to refresh described waveform.The baseline ECG waveform that window 184A is captured before being used to be presented within the nearby sphere that described ECG sensor cluster is placed to described SA knot, the purposes that is used for comparison is with the end of picc of the described expectation that helps the clinician to determine when to arrive at.When user during by the predetermined button that is pressed on detector 40 or the control station button interfaces 32,

window

184B and 184C can present by the selected detected ECG waveform of user.Described waveform in

window

184B and 184C be retained up to by user via pressing button or utilize the selection that other input equipment carries out and the new waveform that causes covered.In pattern formerly, depth scale 124, state/action cue mark 126 and button icon 128 are included on the display 30.Integrity indicator 186 also is included on the display 30, provides the prompting whether described ECG core/electrode pair 158 is operably connected to TLS pick off 50 and patient 70.

Thereby, as top being seen, display 30 is described the two each key element of described TLS mode and ECG mode simultaneously on single screen in one embodiment, thereby provides rich data to help that described conduit distal end is placed on desired locations for the clinician.What please further note is that in one embodiment, the printout of described screenshot capture or selected ECG or TLS data can be saved, print, and are perhaps kept to enable the file record that appropriate conduit is placed by system 10.

Although embodiment described herein relates to the conduit of special structure, for example PICC or CVC, such embodiment only is exemplary.Therefore, principle of the present invention can be extended to the conduit of a large amount of different structures and design.

Figure 18-19B describes to be used for the embodiment of the contact connected structure of cable adapter 132 and fin-shaped adapter 156.Particularly, Figure 18 describes the fin-shaped contact 168 of fin-shaped adapter 156 according to an embodiment, the contact of wherein said back comprises alligator clamp structure 168B, is used for receiving the pin contact 170 (Figure 15) of cable adapter 132 via being limited at the center conical surface 164 in the described fin-shaped adapter or other holes.Figure 19 A and 19B describe the joint scheme according to another embodiment, wherein the pin contact 170 of cable adapter 132 comprises tip spare (barbed feature) 170A, tip spare 170A engages the shoulder 168C on the fin-shaped contact 168 of the back that is limited at described fin-shaped adapter when the center conical surface 164 that is inserted into fin-shaped adapter 156 or other holes, remove ahead of time from described fin-shaped adapter to help prevent described pin contact.Therefore, these embodiments are as the non-limiting example of the various structure of contact terminals that can be comprised with fin-shaped adapter 156, sensor connector bottom 152 and cable adapter 132.What note is that unless limit separately, described contact described herein is understood to include the electrical contact that uses in setting up conductive path.

In the embodiment that will be described below in conjunction with accompanying drawing 20A-32 each is depicted as such device with exemplary connectivity scenario, promptly is used for setting up between patient's aseptic area and non-sterile zone (being the zone outside the described aseptic area) device of conduction or other communication paths.Therefore, embodiment described herein is as the embodiment corresponding to structure, material and/or the composition of the device that is used for setting up conduction or other communication paths.Especially, various embodiment described herein openly is used for passing or get around the embodiment with the isolating sterile barrier of described aseptic area and described non-sterile zone, at least a portion of the conductive path that transmits with the ECG signal that is provided for other the data reception portion parts that are fit to from sensing element (for example described ECG sensor cluster of probe 130) to pick off 50 (being also referred to as TLS pick off or chest pick off in this article) or system 10.What note is, these embodiments only are the embodiment of the various devices that are used for setting up such conduction or communication paths, and can not be considered to the restriction to the scope of the present disclosure.Therefore, it being understood that the device that is used for setting up conduction or other communication paths can be used to transmit ECG signal or other information, the signal of telecommunication, optical signal etc.

As will be seen, the many embodiments that are described are included in the cable adapter that is also referred to as the first connection node herein, this first connection node is operably connected to probe 130 and is included in the described aseptic area, described cable adapter is configured to operationally be attached to the adapter on other parts that are fit to that are included in pick off 50 or system 10, this pick off or adapter are also referred to as second in this article and are communicated with node, and this second connection node is set at outside the described aseptic area.Yet be noted that, the first connection node and second is communicated with node and usually is intended to relate to various AUIs, described AUI provides the conductive path from described aseptic area to described non-sterile zone as described above, to enable the transmission of ECG signal.It being understood that described conductive path is communication paths and comprises electric pathway, light-path etc.In addition, can be utilized with such system, promptly comprise the system of the use of other modes except that the ECG signal, be used for the guiding or the placement of conduit or other armarium at this connection node connectivity scenario of describing and considering.

What further notice is, the embodiment that will follow that description is used to pass the structure of cloth list or other nontransparent sterile barriers is disposed like this, so that convenient clinician is to the touch of the position that is arranged on the connection node beyond the invisible below cloth list/barrier, thus convenient described first and second location that are communicated with nodes be connected.Have, many connector constructions described herein can be configured to the droppable parts of disposable use again, so that the misgivings relevant with infection minimize.

With reference now to Figure 20 A-20C,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.Particularly, Figure 20 A-20C has described cable adapter 232, and cable adapter 232 comprises shell body 234 and is attached to lamellar sword (blade) eyelid retractor 236 of described shell body.Lamellar sword contact 238 is fixing by lamellar sword eyelid retractor 236, so that described lamellar sword contact extends in the groove 240 of described cable adapter.Lamellar sword contact 238 is used for being slipped into when engaging described fin-shaped adapter in the mode described in the embodiment of front when cable adapter 232, creates to scratch (slice) and bore a hole in the cloth list that is placed between described cable adapter and the fin-shaped adapter 256.As before, the shell body 234 of described cable adapter encases (envelop) and protects described perforation, is polluted and damages to prevent described aseptic area.

Figure 20 C illustrates fin-shaped adapter 256 and comprises fin-shaped contact 268, fin-shaped contact 268 be configured to when described cable adapter is slided on the fin-shaped adapter 256 and lamellar sword contact 238 interconnection in fact, thereby set up conductive path by described sheath, so that can pass to pick off 50 via lamellar sword contact 238/ fin-shaped contact 268 joints from the ECG signal of ECG sensing element (for example being above-described described ECG sensor cluster).What note is that the concrete structure of lamellar sword and fin-shaped contact can be different from content described herein.For example, if expectation, the cable adapter can comprise two or more lamellar sword or contacts, is used for engaging with corresponding fin-shaped contact, so that many conductive paths can be established.The composition surface of cable adapter and fin-shaped adapter also can be different from content shown and that describe.In one embodiment, light source can with the fin-shaped adapter or as described herein other adapters comprised, illumination to be provided by cloth list 174 and to provide vision auxiliary aspect the fin-shaped adapter of location, be used for interconnection with the cable adapter.

Seen at Figure 14 A and 14B, in one embodiment, ECG core 158 for good and all is connected to fin-shaped adapter 156.Figure 21 A describes another possible embodiment, and wherein the ECG core is attached to fin-shaped adapter 156 removably via adapter (for example best visible shape of a hoof adapter 270 in Figure 21 B).Figure 21 A also illustrates fin-shaped adapter 156 and for good and all is attached to pick off 50.Therefore, these and other variants in the connectivity scenario of the various parts of system 10 are intended to fall into the scope of the present disclosure.In another embodiment, the electrode of each core is with can be attached from the removable mode of described core, for example connects (snap connection) via buckle.

With reference now to Figure 22 A-22C,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.Particularly, Figure 22 A-22C describes to comprise the cable adapter 332 of groove 372, is used for to be similar to the mode of front embodiment, engages the last tubular 166 that is arranged on the fin-shaped adapter 356 on the pick off 50 slidably.Cable adapter 332 comprises the two-way top medicated cap of settling 374, and pin contact 370 or other pierce through contact and are attached to the two-way top medicated cap of settling 374.

When cable adapter 332 was at first slided on the fin-shaped adapter 356, top medicated cap 374 was positioned in the shown primary importance that does not activated of dotted line among Figure 22 B.Be similar to the embodiment of front, the cloth list is placed between the last tubular 166 and cable adapter groove 372 of fin-shaped adapter 356, for clarity sake is removed.After cable adapter 332 is positioned on the fin-shaped adapter 356,374 on top medicated cap can be pressed into the second position that activated shown in Figure 22 B by the clinician, wherein pin contact 370 be pressed downward by the cloth list and be forced into be arranged on fin-shaped adapter 356 in exercisable joint of corresponding contact.Thereby, cable adapter 332 being placed as shown in Figure 22 C.Except setting up the conductive path by cloth list 174, this joint of pin contact 370 is locked to cable adapter 332 on the fin-shaped adapter 356, to prevent separating ahead of time of described parts.

With reference now to Figure 23 A and 23B,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.Particularly, Figure 23 A describes to comprise pin contact 440 or is attached to the cable adapter 432 of other contacts that are fit to of actuating assembly 442.Actuating assembly 442 comprises lever arm, is used for optionally making pin contact 440 to reduce and by male end 448 opening that limit by housing 446 (actuating assembly is set in the housing 446).The male end of housing 448 is configured to be received by the sensor connector jack (receptacle) 450 on other parts (for example being operably connected to the far module of pick off) that are fit to that are arranged on pick off 50 or system.

For making cable adapter 432 and sensor connector jack 450 interconnection, the male end of cable adapter 432 448 position of being taken contiguous jack 450 on cloth list 174.442 of actuating assemblies by as activate at the lever arm 444 of raising shown in Figure 23 B.Pin contact 440 is forced to decline and by cloth list 174, thereby limits perforation therein.Then, male end 448 can be received in the pick off jack 450 fully, and wherein pin contact 440 operationally is connected with the contact that is fit to of sensor connector jack.Connector scheme shown in Figure 23 A and the 23B applies minimum downward power during interconnection on patient's body for adapter be useful.In addition, actuating assembly 442 makes first to be communicated with node (cable adapter 432) and to be communicated with second in node (the sensor connector jack 450) connection procedure predetermined power is provided, thereby and does not rely on the clinician to setting up the appraisal of exerting oneself of node connection.In another embodiment, actuating assembly 442 activated contact 440 is pierced through by before the cloth list, and housing 446 and pick off jack 450 can be aligned and connect.

With reference now to Figure 24,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.As in Figure 23 A and the shown embodiment of 23B, during node interconnection, this interconnection scheme makes the downward minimum pressure on patient's body.As directed, cable adapter 532 comprises pin contact 540 or other contacts that are fit to that comprised with threaded medicated cap 542, and threaded medicated cap 542 limits screw thread on the side within it.Threaded medicated cap 542 is configured to receive threaded bottom 544 on other parts (for example being operably connected to the far module of pick off) that are fit to that are arranged on pick off 50 or system in the mode of being spirally connected.As before, cloth list 174 is placed between the two.

For making cable adapter 532 and pick off 50 interconnection, taken the position of contiguous threaded bottom 544 and be bolted on the described bottom at the threaded medicated cap 542 of cable adapter on the cloth list 174.This causes pin contact 540 to thrust cloth list 174, thereby limits perforation therein.Further medicated cap 542 is screwed to the bottom and causes on 544 pin contact 540 to engage the contact receptacle 546 that is included in the bottom 544, thereby operationally make described two nodes interconnection.In one embodiment, cable 134 rotatably is attached to threaded medicated cap 542, to prevent the winding (twisting) of cable during being spirally connected.Because via the operation that is spirally connected, the power that is used for connecting these two adapters is laterally guided with respect to the patient, and the connector scheme shown in Figure 24 applies the downward power of minimum for adapter during interconnection on patient's body be useful.What further note is, disclosure intention comprises various spiro connection structures and position and the different medicated cap and the structure at the end.

With reference now to Figure 25 A and 25B,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.In embodiment in front, this interconnection scheme makes downward minimum pressure on patient's body during described node interconnection.As describing in Figure 25 A and 25B, cable adapter 632 comprises that one or more pierces through contact, for example is included in

pin contact

640A and 640B on travelling arm 642A and the 642B respectively.One or more contact receptacle (for

example contact receptacle

644A and 644B) is included on the part (for example the pick off fin 646) or other system units that is fit to of pick off 50.As before, cloth list 174 is placed between cable adapter 632 and the pick off fin 646, to be used as sterile barrier.

For making cable adapter 632 and pick off fin 646 interconnection, the cable adapter is taken the position of proximity sense fin on cloth list 174, thereby travelling arm 642A and 642B across the pick off fin and so that shown in Figure 25 A, pin contact 640A and 640B aim at corresponding contact receptacle 644A and 644B.Then, travelling arm 642A and 642B are slided toward each other, so that pin contact 640A and 640B thrust cloth list 174, and each pin contact limits a perforation in the cloth list.Travelling arm 642A and 642B inwardly slided up to as visible in Figure 25 B, pin contact 640A is located in wherein with 640B and operationally is connected with 644B with corresponding contact receptacle 644A, thereby makes these two nodes interconnection.Laterally guided with respect to the patient owing to be used for connecting the power of these two adapters, the connector scheme shown in Figure 25 A and the 25B applies minimum downward power for adapter during interconnection on patient's body be useful.What further note is that the concrete structure of cable adapter, pick off fin and contact can be different from the clearly content of description of this paper institute.For example, in one embodiment, travelling arm can be configured to the two-way rocking arm of settling, and described rocking arm relative to each other connects with the structure of seesaw.Moreover one, two or more contacts can be included on the travelling arm.

With reference now to Figure 26 A and 26B,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.As directed, the device 730 that is integrated and connected is incorporated in the cloth list 174, to enable to pass wherein exercisable interconnection.In the embodiment that illustrates, the device 730 that is integrated and connected comprises conductive bottom part 734, extends mechanical connector, for example buckle ball 736A and 736B from conductive bottom part 734.

As shown in Figure 26 B, the device 730 that is integrated and connected is fixed in the cloth list 174, to such an extent as to all be attachable with lower member, i.e. other parts that are fit to of the jack that is fit to 740 of the jack 738 that is fit to of cable adapter 732 and pick off 50 the two or system 10.Particularly, cable adapter 732 can be attached to the device 730 that is integrated and connected by buckle, after this device that is integrated and connected can be attached to pick off 50, thereby for such signal provides suitable path, promptly from the ECG sensor cluster in the aseptic area, to be transferred to the signal of the pick off in the non-sterile zone by the sterile barrier of cloth list 174.Should be understood that, in other embodiments, the device that is integrated and connected can comprise other structures, for example different mechanical connectors, as the adapter that rubs, public affairs/female connectors or the like, and can be modified equally at cable adapter and jack on the pick off like this and adapt to different mechanical connectors.Moreover above-described connectivity scenario can be for conversely, and the buckle ball is included on separately the cable adapter and pick off thereby jack is included on the device that is integrated and connected.In addition, although current be to be depicted as single (unitary) parts, the device that is integrated and connected in other embodiments can comprise two or more parts, these parts are attached to each other by the hole in the cloth list that the front limited during it is made.Therefore, intention comprises these and other variants.

With reference now to Figure 27,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.Particularly, Figure 27 describes to be arranged on patient's the outer intermediate module of aseptic area, promptly operationally is connected to the ECG module 750 of the pick off 50 of system 10 via sensor wire 752.ECG module 750 also is operably connected to ECG core 158.In one embodiment, ECG module 750 comprises by the reception of the detected ECG signal of ECG sensor cluster of probe 130 with analyze circuitry needed and miscellaneous part.Like this, the conductive path between probe 130 and the ECG module 750 is set up by the aseptic area that traverses the patient.In the present embodiment, this is to realize by the cable adapter 762 of cable 134.

As depicted in figure 27, cable adapter 762 operationally is attached to the jack 764 of ECG module 750.Go out as shown, cable adapter 762 can comprise sufficiently long handle, described handle makes the clinician aseptic cable adapter can be attached to the jack 764 of non-sterile ECG module 750, and does not touch ECG module itself, thereby prevents that aseptic area is subjected to any infringement.In one embodiment, the handle of cable adapter 762 can comprise for example extendible hook (J-hook) contact, and this hook contact can be operatively attached to the contact that is fit to of ECG module.

Figure 27 also describes a foot switch 1116 that can use with arbitrary embodiment described herein, foot switch 1116 can be placed near on the ground of clinician's both feet, and is used to aspect in conduit put procedure control system function selected.For example, in one embodiment, foot switch 1116 can be used to the ECG waveform image that fixes on system display 30, perhaps in described process or or even after described process finishes, create the printout of display, thereby the record of final conduit placement is provided.Certainly, the Design and Features of foot switch can be revised in the many modes that clearly illustrated and describe in this article.

Figure 28 illustrates another embodiment as the cable adapter of the part of connectivity scenario according to an embodiment, this cable adapter can use with the ECG module 750 of Figure 27 or with other parts that are fit to of system 10, and this connectivity scenario is depicted as the device that is used for setting up conductive path between aseptic area and non-sterile zone.Particularly, Figure 28 describes cable adapter 832, and cable adapter 832 comprises handle and sharp contact 836 or other contacts that is fit in its proximal end.Aseptic protection body 838 is placed between handle 834 and the contact 836.When being similar to mode illustrated in fig. 27 and contact 836 being inserted in the jack 764 of ECG modules 750, the hands that aseptic protection body 838 helps the protection clinicians.Therefore, aseptic protection body 838 plays the effect of additional barrier, prevents unexpected contact of the outer parts (for example the ECG module 750) of clinician and aseptic area.What note is, size, shape and the concrete structure of aseptic protection body and/or other cable adapters can be different from the present embodiment the clearly content of description of institute.

Figure 29 A and 29B illustrate another embodiment again of connectivity scenario according to an embodiment, this connectivity scenario can use with the ECG module 750 of Figure 27 or with other parts that are fit to of system 10, and this connectivity scenario is depicted as the device that is used for setting up conductive path between aseptic area and non-sterile zone.Particularly, Figure 29 A illustrates ECG module 750 and can be encased by sterile bag 850.Adapter (for example top in conjunction with Figure 26 A and the described device 730 that is integrated and connected of 26B) can be incorporated in the described bag.As shown in Figure 29 B, the interior buckle ball of the device 730 that is integrated and connected or other mechanical connectors can be received by the corresponding jack that is fit to 764 of ECG module 750.The cable adapter of system 10 then can be operationally be connected with wild card slam-shot or other adapters of the device 730 that is integrated and connected, thereby sets up conductive path and do not damage aseptic between aseptic area and non-sterile zone.What note is, sterile bag 850 can comprise any or more kinds of in the various suitable materials (comprising plastics).It is also noted that, except this paper the content clearly the described device that is integrated and connected can comprise other connector constructions.In one embodiment, sterile bag does not comprise the device that is integrated and connected, but is pierced through by the pin contact of cable adapter (for example being included in the sharp contact 836 on the cable adapter 832 of Figure 28).

With reference now to Figure 30,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.Particularly, as in the embodiment in front, probe 130 comprises the cable adapter 862 as the first connection node.Also comprise distance sensor adapter 864, and distance sensor adapter 864 operationally is connected to the pick off 50 of system 10 via distance sensor connector-cable 866 as the second connection node.Cable adapter 862 and distance sensor adapter 864 operationally are connected to each other along connecting interface 868.The cloth list 174 that plays the sterile barrier effect is placed in the connecting interface 868 between cable adapter 862 and the distance sensor adapter 864, and the cloth list that is fit to pierces through structure and is comprised with cable adapter and distance sensor adapter, sets up the conductive path by the cloth list.Thereby the present embodiment discloses such embodiment, and wherein the second connection node is remotely located with respect to pick off 50.

With reference now to Figure 31,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path.Particularly, as top described in conjunction with Figure 30, the present invention includes operationally along connecting interface 868 cable adapter 862 connected to one another and distance sensor adapters 864.Distance sensor adapter 864 in the present embodiment is placed on adjacent pipes and inserts in the zone at position 73, on this zone, be limited at cloth list 174 (for clarity sake, the part of cloth list is omitted) in fenestra (fenestration) 880 settled like this, make the clinician can insert the position near (access to) between resting period at conduit.Before the zone that centers on the insertion position was sterilized and thinks that the conduit insertion is prepared, under the situation of using binding agent, adhesive tape etc., distance sensor adapter 864 was attached to patient's adjacent pipes and inserts the skin at position 73.Therefore, when the insertion position was sterilized, distance sensor adapter 864 also was sterilized.After a while, when cable adapter 862 was connected to distance sensor adapter 864, the clinician can hold distance sensor adapter 864 and not damage patient's aseptic area.Be understood that the concrete structure of cable adapter and distance sensor adapter can change and still belong in the scope of the present embodiment.

With reference now to Figure 32,, according to an embodiment connectivity scenario is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up conductive path.Particularly, Figure 32 illustrates the function at US, system 10 adopted as top in conjunction with Fig. 3 A and the described detector 40 of 3B.No mycoclena 900 is placed on the detector 40, so that detector enters patient's aseptic area.Connecting interface (for example jack 910) is included on the detector 900 and disposed like this, but with cable adapter 920 are adapters operationally.For example, in one embodiment, cable adapter 920 comprises the pin contact that thrusts no mycoclena 900, connects to prevent that aseptic area from being polluted by such mode and jack 910.By this way, operationally with as second detector 40 that is communicated with node be connected as the first cable adapter 920 that is communicated with node.For example visible in Figure 31, detector 40 is operably connected to system control position 20 again, so that the other system parts that the ECG signal that is received via cable adapter 920 by the ECG sensor cluster of probe 130 can as described abovely be transferred into control station, pick off 50 like that or be used to handle.In another embodiment, jack 910 or other connecting interfaces that is fit to can be included in detector 40 is connected on the cable of system control position 20.The concrete contact structures of jack 910 and cable adapter 920 can change according to those skilled in the art's understanding.For example, in one embodiment, the device that is integrated and connected (for example shown in Figure 26 A and the 26B) can be incorporated in the no mycoclena.What further note is although comprise plastics in the present embodiment, not have mycoclena as described herein and can comprise that other materials that are fit to provide aseptic.

With reference now to Figure 33,, describes to be used between aseptic area and non-sterile zone, setting up the device of conductive path according to an embodiment.Go out as shown, cable 134 comprises the wireless module 950 that is included among the aseptic area, wireless module 950 plays the effect of the first connection node, be used for ECG transfer of data that (via RF or other frequency or frequency ranges that is fit to) will receive from the ECG sensor cluster of probe 130 wirelessly to as the second data reception portion part that is communicated with node, for example the parts that are fit to of other of pick off 50 or system 10.Wireless module ground electrode 952 operationally is connected with wireless module 950, is used for placing in the aseptic area at adjacent pipes insertion position 73.System earth electrode 158A extends from pick off 50, is used for aseptic area outside and adjacent pipes is inserted the position placement of position 73 and wireless module ground electrode 952.A kind of possible placement location that is used for system earth electrode 158A is for as Figure 33 described below patient's arm.As in the embodiment in front, system reference electrode 158B is placed on patient 70 the lower trunk or other positions that is fit to.What note is, one or more in can be in every way of wireless module and system control position are planted and are disposed as discussed herein, and be included in the parts that are used for transmission of wireless signals and reception that this does not describe in detail, for example microstrip antenna (patch) or other antennas, signal converter or the like.

In system by under with the situation that mode disposes as shown in Figure 33, what system earth electrode 158A can be for electric driving, thus it generates the voltage of being surveyed by passive and wireless module ground electrode 952, provides its close position with respect to the system earth electrode.This makes that two ground electrodes are iso-electric basically, thereby make wireless module 950 can use wireless module ground electrode 952, and the ECG signal is from the ECG sensor cluster (for example heart yearn 138 in one embodiment (Figure 12 C-12E)) of probe 130, detect the ECG data and wirelessly with the ECG transfer of data to pick off 50, be used for comparing, to obtain the P-wave-wave shape (as Figure 16) of expectation with the data of surveying by system reference electrode 158B.In one embodiment, data relatively be between the ECG data that obtain by the ECG sensor cluster of probe 130, wireless module ground electrode 952 and system reference electrode 158B differential ratio.In one embodiment, system earth electrode 158A and wireless module ground electrode 952 are similar, can be for passive and be not electric driving.It is also noted that, be transferred to pick off 50 or other system parts (for example control station 20) before, mimic ECG data can be digitized or be handled by wireless module 950.

Figure 34 incites somebody to action again another wireless topology according to an embodiment and is described as such device, promptly is used for setting up between aseptic area and non-sterile zone the device of conductive path.Go out as shown, comprised with pick off 50 at the anelectrode 954A of position A with at the negative electrode 954B of position B, and be positioned on patient 70 the trunk, and the positive wireless module electrode 956 that is indicated in position C is comprised with radio node 950, and positive wireless module electrode 956 is positioned on patient's adjacent pipes insertion position 73 or adjacent pipes is inserted in the position 73.The ECG sensor cluster of probe 130, heart yearn 138 in one embodiment for example plays the effect of negative electrode (being shown in D place among Figure 34 with its final position) at the wireless portion of the structure of being described.What note is that in one embodiment, position A and the B of

electrode

954A and 954B can be changed respectively on patient's body, come to receive coherent system 10 for best ECG signal.

In the present embodiment,

electrode

954A and 954B play the effect of first independent source for the bipolar ECG signal of sampling.ECG data from these electrodes are digitized, and via making the outer interconnected cable of control station (path 1) of pick off 50 and aseptic area be transferred into control station 20 or other system units that is fit to.Wireless module electrode 956 and ECG sensor cluster play the effect of second independent source for the bipolar ECG signal of sampling.ECG data from these electrodes are digitized, and are sent to control station 20 wirelessly via the wireless module in aseptic area 950 (path 2).Therefore, in the present embodiment, wireless module 950 plays the effect of the first connection node, and the wireless receiver of control station 20 plays the effect of the second connection node, is used for carrying out between two nodes the conversion of ECG signal.What note is that in other embodiments, the polarity of above-mentioned electrode can be conversely.

1 and 2 the two ECG signal that receive carry out the baseline rectification by the circuit that is fit to of control station 20 along the path, to adjust at DC biasing and drift.After such rectification, can generate unaltered reference or baseline, for example visible P-wave-wave shape 176A in Figure 35 A from path 1.Similarly, generate from path 2 as visible P-wave-wave shape 176B in Figure 35 B, such waveform is advanced by the heart towards the patient along with the probe in the conduit 72 130 and changes.During such propelling, deducted from P-wave-wave shape 176A from the waveform 176B in path 2 from path 1, for example utilize the digital differential amplifier.Thisly deduct all total components that remove by the waveform that each characterized in the signal, and for example visible, make control station 20 only describe difference in these two signals via its display 30 by the waveform 176C shown in Figure 35 C.During conduit advances, then can easily be observed from the change in the P-ripple of the waveform in path 2.Therefore, the present embodiment makes the numeral of the ECG data that must be characterized show it is easily observable, and the physics that prevents to be used for the sterile barrier (for example surgical operation cloth list) of such transfer of data passes.

What note is, in other embodiments, wireless module electrode 956 can comprise other structures, comprises the conducting element that is embedded in the guiding device sheath, contact with patient's blood flow, this guiding device sheath is provided with by inserting position 73 between resting period usually at conduit.In one embodiment, guiding device can comprise adapter on its portions of proximal, and it is carried out with contacting of radio node 950.

It is also noted that according to embodiment described herein, one or more in the various wireless protocols can be used to transmitting wireless signals, comprise in the standard of IEEE 802.11 families one or more or the like.It is also noted that, in one embodiment, wireless module can be included in as the no mycoclena described in the embodiment in front by the adapter that sheath connects the wireless module electrode with being used for operationally, to pick up this module in aseptic area, perhaps wireless module self is included in the sheath.Certainly, can also adopt additive method that wireless module is remained in the aseptic area.In one embodiment, wireless module can comprise button, the further control of enabled systems 10 in the aseptic area of this button.

Figure 36 illustrates in one embodiment, and pick off 50 can be modified (retro-fitted) for having wireless module 960, so that the signal that is received by pick off can be transferred to other parts that are fit to of control station 20 or system 10 wirelessly.For example, the ECG data that received by ground connection and

reference electrode

158A, 158B (Figure 34) can be received by pick off 50, are transferred to system control position wirelessly via wireless module 960 then.Wireless module 960 can comprise antenna or other transmission parts and can operationally be connected to pick off 50 via sensor wire 962 or other interfaces that is fit to.What note is, wireless module 960 can be used in combination with other embodiments described herein, comprises the embodiment of being described among Figure 10 and 33 for example.

Figure 37 illustrates retaining member according to an embodiment, is used for preventing that fin-shaped adapter 156 is from sensor connector bottom 152 or other jack accidental separation that are operably connected with the fin-shaped adapter.Go out as shown, fin-shaped adapter 156 comprises the keeping arm 970 that is attached to the fin-shaped connector body pliable and toughly.Keeping arm 970 comprises tongue (tab) 972, when fin-shaped adapter 156 was received among the pick off groove 152A (Figure 14 A) slidably, tongue 972 was sliding on 152 edges that comprised (lip) 974, adapter bottom of pick off 50 and is engaging with edge 974.Tongue 972 prevents that with engaging of edge 974 fin-shaped adapter 156 accident in use from removing.When fin-shaped adapter 156 from sensor connector bottom 152 remove be expectation the time, keeping arm 970 is lifted so that tongue 972 974 breaks away from from the edge, after this fin-shaped adapter can with under the situation that pick off groove 152A engages not slided.Such structure can be used or use separately with other retaining members (for example recessed 168A (Figure 13 D)).What note is, in other embodiments, can adopt various modifications and structure to help to keep joint between fin-shaped adapter and the adapter.For example, in one embodiment, keeping arm can operationally be attached to one or more in the fin-shaped contact 168 (Figure 13 D), thereby the replacement of the fin-shaped connector components that keeping arm or other are fit to (for example laterally lift mobile, extruding etc.) makes one or more fin-shaped contact break away from from bottom contact (Figure 15), thereby reduces the whole retentivity that joint provided by fin-shaped contact and bottom contact.What further note is that these principles can be applied to other connector schemes that are disclosed or are intended to comprise except fin-shaped adapter described herein.

Except the top embodiment that various connectivity scenarios is depicted as such device, promptly be used between aseptic area and non-sterile zone, setting up the device of conductive path, can utilize other to dispose according to those skilled in the art's understanding and realize identical functions.Other configurations like this can comprise, for example the ECG signal is from the probe to the pick off or the wireless transmission of system unit, comprise that the electric conductivity in the cloth list is spirally connected, comprises electric conductivity window (for example, being made of markite or metal forming) in the sterile sheet or the like.In another embodiment again, the proximal end of probe/seal wire self can be used to pierce through the cloth list, enters into adapter on the pick off with reception.In this case, do not have cable to be included on the proximal end of probe, and probe self plays the effect of conductive path, be used for the ECG signal is transferred to pick off on patient's chest from the probe sensor assembly.The silk that such structure can allow to use probe/seal wire as the described herein to carry out conduit is gone up placement.Like this, it is limitation of the present invention that top embodiment should not be understood that by any way.

Figure 38 illustrates conduit 982, an embodiment of the conduit that is used as the catheter placement system 10 that can describe in embodiment disclosed herein.Conduit 982 comprise be placed in contiguous distal end portion 982B place (yet, other positions along described conduit also are possible) conducting loop-shaped band 984, conducting loop-shaped band 984 plays the effect of ECG pick off or electrode, is used for detecting when conduit is inserted into patient's vascular system at least in part the ECG signal of binding up one's hair out from patient 70 heart.Lead 986 extends and is embedded into (for example passing through co-extrusion) catheter wall in one embodiment along the length of conduit 982, is used for and being connected of the outside ECG signal receiving part of patient outside.Be noted that except above-mentioned those and those skilled in the art understand, this is an exemplary of conduit and ECG sensors electrode structure.In addition, it is the U.S. Patent application No.12/545 of " conduit tube component (Catheter Assembly Including ECG Sensor and Magnetic Assemblies) that comprises ECG pick off and magnet assembly " that other possible structures are disclosed the exercise question of submitting on August 21st, 2009, in 762, incorporate its full content into the application by reference.

Figure 39 illustrates the conduit 982 that is used for system's 10 uses that comprise ECG sensor cluster 990 according to an embodiment, and wherein said conduit comprises a plurality of ECG pick offs or

electrode

994A, 994B and 994C.Electrode 994C is positioned in adjacent pipes distal end portion 982B place, and remaining

electrode

994A and 994B are positioned in adjacent electrode 994C place on the described conduit.Each electrode is operably connected to conductive path separately, the lead that extends along the length of conduit from the electrode proximad for example, thus make detected ECG signal can be sent to outside TLS pick off 50 or other system units that is fit to.Electrode 994A-994C can dispose with in the multiple structure of the ECG signal that detects patient's heart one or more to be suitable as pick off.Moreover, seal although be shown as, what conduit 982 can be for opening in one embodiment.

As shown in Figure 40 A-40C, ECG sensor cluster 990 can be used to determine the proximity of conduit distal end portion 982B to the SA knot, and wherein in the embodiment that illustrates, the sensor cluster of conduit 982 comprises two electrode 994A and 994B.In Figure 40 A, when conduit distal end portion 982B ties near SA, respectively the P-ripple 996A of the ECG waveform that detects by

catheter electrode

994A and 994B and 996B the two increase on the P-wave amplitude is shown.Yet because the position of its contiguous relatively more SA knot, electrode 994B illustrates the P-ripple that has relatively by a larger margin.For example, be illustrated with 998 as stack by 10 detected P-ripple 996A of system and 996B.For example, observe this relation on the system display can be for the clinician provides required information between resting period at conduit, thereby the propelling that helps conduit distal end portion 982B to tie towards SA.

Figure 40 B illustrates as two

electrode

994A and 994B and ties when equidistant with respect to SA, and the amplitude of P-

ripple

996A and 996B is about equally, and this fact is further illustrated by the stack 998 of P-ripple.In Figure 40 C, distal electrodes 994B ties further from SA relatively than electrode 994A, and its corresponding P-ripple 996B is less with respect to P-ripple 996A like this.Being noted that the type of electrode and number can be different from shown herely goes out.

In another embodiment, filtering can combine with the use of ECG electrode 994A, the 994B of conduit 982 described here and carry out, wherein the part by the ECG waveform of electrode detection all is removed except P-ripple part, and the difference that only stays in the P-ripple that is detected between these two electrodes is described.This process is similar to aforesaid in conjunction with process that Figure 34-35C carried out.

Figure 41 A-41C describes the various possible state at ECG electrode integrity indicator 186, also is shown as on the screenshot capture 178 of the system display 30 among Figure 17 shown.Integrity indicator 186 is icons shown on system display 30, and be the part that connects the integrity parts, to utilize the connection status of the various ECG signal paths of external sensor 50 check, promptly connect whether closed and whether be ready in the conduit put procedure, use.The check of such lead-in wire is useful, if having to remove sterile sheet and restart put procedure when placing sterile sheet and setting up that various ECG electrodes do not connect rightly before patient's the aseptic area avoiding.

In Figure 41 A, it is closed connection to external sensor 50 that integrity indicator 186 illustrates current.On the contrary, the connection that Figure 41 B illustrates between pick off 50 and the ECG electrode 158 (Figure 14 B) is closed, indicates by the bound symbol 1004 of band shade.In addition Figure 41 C illustrates, and the connection between the ECG pick off of pick off 50 and probe 130 (for example the heart yearn 138 among Figure 12 C and the 12D is via cable 134 and cable adapter 132) also is closed, indicated as the bound symbol 1006 of band shade.Therefore, the integrity indicator view among Figure 41 A characterizes the connection status shown in Figure 14 A, and the indicator view among Figure 41 B characterizes the connection status shown in Figure 14 B, and the indicator view among Figure 41 C characterizes the connection status shown in Figure 14 C.

System 10 can use and connect integrity parts one or more in every way and confirm the state of above-mentioned connection, and described connection integrity parts for example comprise the electric capacity that comprised with pick off 50 and/or control station 20 or inductance sensing circuit, method, time or frequency bounce technique technology based on impedance or the like.A kind of possible connection integrity component system based on the balance of voltage illustrates with 1120 in Figure 41 D.Particularly, shown in Figure 41 D, the circuit of system 1120 comprise first resistance to 1120 with the amplifier 1124 that operationally is connected (for example instrument amplifier) another parts as native system via communication line 1126.Second resistance to 1128, amplifier 1130 and 1132, analog-digital converter (" ADC ") 1134 and processor 1136 also be included in the described system and shown in Figure 41 D and interconnect.In one embodiment, processor 1136 is included in the outside TLS pick off 50, but can be merged in the other system processor or be included in the miscellaneous part, for example in the control station 20 in embodiment.The various ECG electrodes of system 10 are illustrated the body that is attached to patient 70, promptly such as inside ECG pick off (E1 among Figure 41 D) with the probe heart yearn 138 of the structure shown in Figure 12 A-12E, and outside ECG electrode 158 (E2) of the external reference shown in Figure 14 A-14C and second outer electrode (E3) the two.

In preparation at using system 10, integrity checking system 1120 can be used in one embodiment to guarantee outside ECG electrode be connected to rightly patient 70 body and system 10 outside TLS pick off 50 the two.For example be driven to predetermined value with the reference voltage Vref shown in 1140 by manostat, for example 4 volts, and the voltage at outer electrode E3 place is maintained at low relatively value, for example 2 volts.Come from electrode 1 among Figure 41 D and 2 magnitude of voltage V1 and V2 respectively by on average to generate common-mode voltage Vcm with 1142 expressions.In one embodiment, when being sampled via ADC 1134, processor 1136 monitoring Vcm.When outside ECG electrode E2 and E3 were connected to patient's body and TLS pick off 50 rightly, Vcm numerically will be dragged down, and in one embodiment near about 2 volts, yet other values also are possible.Yet if one or two among outer electrode E2 and the E3 is not connected rightly, Vcm will be drawn high the value to Vref, perhaps be about 4 volts in the present embodiment.Like this, can determine the connectedness of outside ECG electrode by the monitoring of 1136 couples of Vcm of processor.These data relevant with the connectivity state of outside ECG electrode can be sent to display 30 by processor 1136, are used for describing by the indicator 186 on the display 30 shown in Figure 41 A-41C.

Figure 42 wherein adopts passive lead-in wire continuity check system according to the connection integrity modular construction that an embodiment illustrates and another is possible, eliminates any needs of the lead-in wire injection current that the various ECG electrodes from system 10 are extended.As directed, radiating element 1010 is included in relatively close such as the ECG contact conductor place on pick off 50.Radiating element 1010 is configured to launch the signal of given frequency.ECG lead-in wire (line of for example outside ECG electrode 158 and cable 134) does not have the seedbed as antenna and detects radiating element 1010 radiating signals.When the ECG lead-in wire was appended to pick off 50 rightly, the antenna effect of ECG lead-in wire was minimized, so that the radiation signal that appears on the ECG lead-in wire is suppressed.Pick off and/or control station circuit are configured to detect the radiation signal on the present ECG lead-in wire like this and itself and threshold signal level are compared.If detected radiation signal is on described threshold value, System Reports ECG lead-in wire is not connected rightly.When detected signal was lower than described threshold value, the described lead-in wire of System Reports was connected rightly.This structure is passive and need not to ECG lead-in wire transmission current to check the connection integrity of checking at access path.

In one embodiment, the connection of Figure 42 checks that sketch map can be configured, and whether the signal level that consequently appears at the different brackets on the lead-in wire will indicate the son in ECG electrode upstream to connect closed.In another embodiment, natural frequency 60Hz, the 120Hz or the natural sign circuit noise among the 180Hz that appear at naturally on the lead-in wire can be used to detect, and eliminate the needs to radiating element 1010 thus.

It being understood that other icons and design can be used to realize in conjunction with the described function of Figure 41 A-41C, and this connection status inspection can change according to the modification that catheter placement system is made.Certainly, other visions or audible indication can be used to pass on the electrode connection status.

Figure 43 A-43B describes to comprise the details of the probe structure of a pattern, described probe was not conformed to and is desirably stayed conduit cavity when described pattern for example was used for being pruned (trim) before conduit 72 is being inserted into patient 70, checked that whether this moment probe 130 is by inadvertently cutting (cut).As directed, in one embodiment, probe 130 can comprise heart yearn 1014 and a plurality of magnetics 1016 that is covered by pipe box (tubing sleeve) 1018, and the conductive epoxy 1020 that is included in the probe distal end portion.Conductor loop 1024 is included in the probe and at the distal end portion 130B of probe 130 and forms the loop, thereby forms circuit when suitably being connected with system 10.Thus, conductor loop 1024 limits the successional continuous circuits of checking the probe distal part.If probe is inadvertently cut, for example to prune by the inappropriate conduit as shown in Figure 43 B, described loop is continuity check failure open circuit and described, the expression catheter tip is compromised.Continuity check can be performed before conduit 72 is inserted into patient's vascular system, to prevent the catheter guidance problem after inserting.In another embodiment, conductor loop 1024 effect that can be configured to be exposed to blood samples of patients and additionally play the ECG electrode.

Figure 44 illustrates one in many may the change of previous embodiment, and wherein conductor loop 1024 is implemented as the flat lead of being partial at the plane inner bending of minimum thickness.Flat lead like this can be used in the probe of the structure that having shown in Figure 44 prebend.In addition, in one embodiment, if desired, such line enables that probe bends towards will be by the direction along the control of axle.Really, in one embodiment, tension force can be endowed described flat lead, with the distal part that for example causes probe 130 as shown in Figure 44 optionally from the straight warp architecture that turns to.Should be noted that the embodiment of just having described can realize that described probe has in the various structures of aspects such as structure, size with such probe.In other embodiments, be noted that in other embodiments that other technologies (for example comprising the pin check that uses time domain or frequency domain bounce technique) can be used to guarantee that described probe is not cut or is compromised.

Figure 45 and 46 describes to be used to prevent the unexpected proximad propulsive mechanical conceptual of probe 130 in conduit 72.Particularly, Figure 45 illustrates the spherical mechanical interference member 1028 that is included on the probe distal end portion 130B, to hinder probe retraction conduit cavity.Figure 46 illustrates another embodiment, and wherein said probe distal end portion 130B comprises the extension interference member 1028 that is diverted.Certainly, the mechanical interference member of many different sizes and shape be can utilize, arrow-shaped, sphere or the like comprised.

Figure 47 A and 47B describe the auxiliary unjustified electric scheme of distal end portion that prevents conduit 72 and probe 130.As directed, conductive strips 1032 are embedded into described conduit, with two current-carrying part 1036 electrical communication of probe 130, non-conductive probe portion 1034 is placed between described two current-carrying parts 1036.When probe distal end portion 130B was alignd the distal end portion 72B of conduit 72 rightly, more the probe current-carrying part 1036 in distally was connected to the more probe current-carrying part 1036 of nearside conductively via the conductive strips 1032 that embed conduit.Yet, if probe and conduit

distal end portion

130B, 72B be alignment not, then do not have such conductive path to be established, and the disappearance in this path can pick off 50, control station 20 or other parts that are fit to by system 10 detect, to enable its correction.

Figure 48 describes to be used for to be placed in the conduit put procedure a possible embodiment of the two ECG electrode assemblies 1040 on patient 70 the skin.As directed, assembly 1040 comprises

bipolar electrode

1042A, 1042B, is used to simplify the single disc of ECG lead placement.Also comprise corresponding lead-in wire 1044.In other embodiments, if desired, the ECG electrode assemblie can comprise more than two electrodes.

Figure 49 illustrates an embodiment of the outside ECG outer electrode assembly on the skin that is used to be placed on patient 70, comprises aforesaid fin-shaped adapter 156 and outside ECG electrode 158.Figure 1048 is positioned on the surface of each electrode 158, and figure 1048 comprises that assist clinicians is placed on the ECG electrode diagram that is fit to the position on patient's the body.This assists may be unfamiliar with the clinician who is used for the suitable placement location of electrode on patient's body 70.Diagram and concrete electrode structure can change according to system design.

The display (for example display 30 of the system 10 of Figure 10) that Figure 50-61 describes to be used at catheter placement system is gone up the various possible embodiment that shows the ECG data, is used for the vascular system that assist clinicians places the conduit to patient 70.In the many embodiments that will follow, present and the standard method that shows the ECG data is modified and helps conduit and place and terminal localized affirmation.Like this, it can be useful that following demonstration and computational methods subtend clinician present data.

Figure 50 illustrates feedback that audible (audible) or other are fit to can be in conjunction with showing that ECG trace (for example at the ECG trace 1050 shown in this) be utilized, and described feedback sort is similar to the trace history window of being described on the indicator screen sectional drawing 178 in Figure 17 182.Particularly, in one embodiment, sound or other indications can be relevant with the one side of the ECG waveform of ECG signal.In the present embodiment, the amplitude of the P-ripple 1052 of each waveform 176 in audible prompting and the ECG trace 1050 is associated.Along with the variation as shown in figure 50 of P-wave amplitude, the audible prompting can correspondingly change.Audible prompting can be modulated in frequency, volume, seriality aspects such as (for example clicking relative continuous tone separately).

Figure 51 illustrates the flow chart of an embodiment of the method for describing, and described method is used for being correlated with and producing audible or other feedbacks with regard to the one side of ECG waveform 176 (for example amplitude of P-ripple 1052).This method is in that go up in whole or in part can be by the suitable parts (for example being included in the circuit in external sensor 50 or the control station 20) of system 10, and perhaps other conduit or armarium place systems that are fit to are carried out and/or controlled.In step 1056, in the conduit put procedure, the ECG signal data is sampled in the mode that has been described such as the use of coupling system 10 in the above.In step 1058, the ECG waveform is identified from the ECG signal data that is sampled.In step 1060, the P-ripple of ECG waveform partly is identified.This can realize to determine existing with the position of P-ripple 1052 with the pre-loaded P-mode plate of standard by the part such as more described waveform.In step 1062, determine the amplitude peak of P-ripple then.In step 1064, P-wave amplitude peak value is relevant with corresponding audible or other feedback that is fit to output.In one embodiment, this step can be determined in advance and store by system 10, perhaps can be dynamically automatic or controlled by the user input.In step 1066, produce output then.Be noted that in other embodiments output can be except the part of audible as has been described, comprise for example visual, light/sound combination, mechanical movement (vibration) and/or other sensory cues, perhaps aforesaid combination.

Figure 52-55 uses the method that Figure 51 described, and provides the further embodiment of visual output that can be relevant with the many aspects (for example P-wave amplitude of each detected ECG waveform) of ECG signal data.For example, Figure 52 illustrates one and shows embodiment, and wherein the P-ripple 1052 of each ECG waveform 176 is identified and utilizes color highlighted to distinguish other parts of P-ripple and described waveform.In one embodiment, described color can change according to the variation on the P-wave amplitude.

In Figure 53, the peak amplitude of the P-ripple 1052 in each waveform 176 is to follow the trail of as the band color on ECG trace 1050 of time function or the dash area 1070 of band shade.Particularly, during conduit inserted, along with the ECG sensor cluster of conduit tube component (for example conduit and/or probe) other knots near SA knot or heart, the P-ripple 1052 of ECG waveform 176 changed on amplitude usually continuously.Normally usefully, when such variation takes place, on system display 30, show the amplitude of P-ripple 1052.Can use the bar (bar) of line or belt color to depict the amplitude of (trace out) past peak value.By this way, the comparison between the current and last peak amplitude can be carried out in the mode of routine.No matter whether trace strides display is moved, if perhaps this trace can utilize this display mode still for static and be refreshed by the mobile bar that sweeps away (sweep across) described display.

In case Figure 54 illustrates P-ripple 1052 and falls under the previous level, as visible in the leftmost side part of the ECG of Figure 54 trace 1050, another color of dash area 1070 or shade can be used to illustrate different between nearest peak value and the first previous peaks.Alternatively, horizontal line 1074 can be used to depict the peak value as each the P ripple 1052 among Figure 55.Line 1074 can or not have at shaded portion 1070 to use under the situation of dash area 1070.Certainly, many other such tracking embodiments and visual indication can design according to these principles.

With reference to Figure 56 A-57B, many aspects of the convergent-divergent control of ECG trace 150 when in the trace history window 182 that is displayed on system display 30 are for example described.In typical ECG device, the speed that the ECG waveform shows is constant.Yet people's heart rate is not constant, and the ECG wave form varies with each individual with the interval.May be advantageously, the observer can change the number of waveform and/or waveform and be displayed on time quantum on system display 30 or other devices that is fit to.This allows more or less ECG waveform to be shown.In one embodiment, the clinician can regulate and show that setting is shown to define how many ECG waveforms 176, and how long perhaps described waveform will be shown.In one embodiment, user can be selected from a series of discrete demonstration times that limit in advance or waveform option or described the setting can the person of being to use limits.In another embodiment, the control that is provided with in the demonstration of ECG trace 1050 can dynamically or statically independently be controlled by system 10.

As the variable embodiment of top ECG trace time window, Figure 56 A illustrates the ECG waveform 176 that the standard speed with four waveforms as the part of trace 1050 is shown in described window, and Figure 56 B illustrates the ECG trace window of the increase that comprises eight waveforms.Similarly, Figure 57 illustrates the ECG Wave data that is shown with five seconds standard trace speed, and promptly each waveform 176 keeps showing about five seconds; And Figure 57 B illustrates the ECG waveform that is shown with relative longer about 10 seconds speed (being double standard trace speed), so that being close together relatively of occurring of peak value.Shown in Figure 56 A-57B, the physical width of ECG trace window is consistent, and wherein only has the amount of the waveform that is shown in this to be modified.

Figure 58 illustrates the flow chart of an embodiment of the method for describing, and described method is used for showing the ECG signal data with top in conjunction with the described mode of Figure 56 A-57B.Be noted that this method is going up in whole or in part and can carried out by the parts (for example being included in the circuit in external sensor 50 or the control station 20) that are fit to or other conduit or armarium place systems that is fit to of system 10.In step 1080, in the conduit put procedure, the ECG signal data is to be sampled such as the described mode of the use of top coupling system 10.In step 1082, ECG waveform (for example waveform 176 among Figure 56 A-57B) is identified from the ECG signal data that is sampled.In step 1084, the parameter of display window (for example being used for the trace history window 182 shown in Figure 17 of ECG trace 1050 of displayed map 56A-57B) is defined.These parameters can for, for example will be included in the number of the ECG waveform in the described window, or each waveform remains on the time quantum on the screen.Shown in step 1088, described parameter can limit or independently limit and with static (for example setting in advance in factory) or dynamically (for example by described system according to feeding back from main regulation) mode is controlled for user.It being understood that described parameter can comprise for example waveform height, line width etc. about other demonstration aspects of ECG trace or waveform.In addition, described parameter can be defined, so that for example before being refreshed, zero, one, two or more a plurality of ECG waveform be displayed in the described trace window.

In step 1085, the ECG waveform is shown according to the display window parameter that is limited.As shown, in one embodiment, step 1085 can comprise step 1086 and 1090.In step 1086, if allowed ECG waveform and previous waveform combination by the parameter that limits in the step 1084.In step 1090, when being allowed by the parameter that limits in the step 1084, the ECG waveform is shown with any previous waveform.

Figure 59 illustrates discrete trace window, and as has been described, wherein in the conduit put procedure, single ECG waveform 176 is shown and is periodically refreshed when new waveform is recognized by system 10.For example, such trace window of being reflected of indicator screen sectional drawing 178 as shown in Figure 17 is used to current ECG waveform window 180 and

window

184A, 184B and the 184C of system display 30.As has been described, ECG waveform 176 comprises P-ripple 1052 and QRS wave group 1096.Ratio between the peak value size of P-ripple 1052 and QRS wave group 1096 sizes can be displayed in the trace window with the form that numerical value (shown in Figure 59) or other are fit to, and assist clinicians is determined the variation of ECG waveform when being pushed into the vascular system by patient 70 at conduit 72.When each new ECG waveform was depicted in indivedual trace windows, ratio was updated.

Figure 60 illustrates the flow chart of an embodiment of the method for describing, and described method is used for showing the ECG waveform with top in conjunction with the described mode of Figure 59.Be noted that this method is going up in whole or in part and can carried out and/or be controlled by the parts (for example being included in the circuit in external sensor 50 or the control station 20) that are fit to or other conduit or armarium place systems that is fit to of system 10.In step 1100, in the conduit put procedure, the ECG signal data is sampled in the described mode of the use of top coupling system 10.In step 1102, ECG waveform (for example waveform among Figure 59 176) is identified from the ECG signal data that is sampled.In step 1104, the P-ripple of ECG waveform 176 partly is identified.This can for example realize to determine existing with the position of P-ripple 1052 with the pre-loaded P-mode plate of standard by the part that compares waveform.

In step 1106, the ratio between the size of the size of P-wave amplitude and QRS wave group amplitude 1096 is determined.In one embodiment, this step can comprise the amplitude peak of determining the P-ripple, from the size of ECG waveform 176 identification QRS wave groups 1096 and definite QRS wave group size.In step 1108, ECG waveform 176 is displayed on such as in one in the current ECG waveform window 180 of system display 30 (Figure 17) or among

window

184A, 184B and the 184C.If desired, waveform 176 can utilize P-ripple/QRS wave group ratio data of obtaining by step 1106 to show.Shown in Figure 60, process flow can be repeated, and with when new ECG waveform is produced and detects, obtains and shows described new ECG waveform.

Step 1110 comprises the freeze picture output intent option, and wherein user can be selected shown ECG waveform 176 and it is fixed in display, interrupts the repetition of process flow thus, prevents alternatively that perhaps the waveform that newly obtains is shown.Moreover, can execution in step 1112 during described process flow, wherein relevant with the ECG waveform of being discerned data are sent to storage location or device.If desired, stored image can be displayed on then such as in one among window 184A, the 184B of system display 30 (Figure 17) and the 184C.

The purpose that Figure 61 illustrates for recorded and stored/document can be printed and use an embodiment who places record 1114 with the conduit of the appropriate placement of check conduit 72 in patient 70 vascular system.In one embodiment, record 1114 can comprise beginning ECG waveform 176A and final ECG waveform 176B, ECG waveform when the ECG waveform that beginning ECG waveform 176A is characterized in conduit 72 when being introduced patient's vascular system first, the distal end portion that final ECG waveform 176B is characterized in described conduit are positioned in its contiguous patient's the desired locations of heart or other positions that is fit to.The characterization image 120 of pick off 50 can be comprised by the probe distal end portion icon 114 on being depicted in sensor image, characterizing the final placement location of described probe, and also characterizes the final placement location of conduit thus.Date, time, patient ID etc. also can be included in the record 1114.In one embodiment, be used for clinician or responsible party the signature the place also can be comprised.In one embodiment, record 1114 can be for revisable via 10 persons of being to use of system, thereby allow the customization at various hospitals and clinic operation and demand.The printout of record 1114 can be carried out via the suitable button that is included on US detector 40, the system control position 20 etc.In another embodiment, if desired, foot switch 1116 shown in Figure 27 or other interfaces that is fit to can be used to catch and print record 1114.

Figure 62 illustrates purpose for recorded and stored/document can be printed and use another embodiment again that places record 1114 with the conduit of the appropriate placement of check conduit 72.In one embodiment, record 1114 can comprise three windows, and wherein each window is described sensor image 120 and selected terminal position and ECG Wave data.For example, record 1114 among Figure 62 illustrates the left window, middle window and right side window, described the left window is included in beginning ECG waveform 176A and the corresponding ECG trace 1050 of conduit 72 when being introduced vascular system first, described middle window comprises the ECG trace 1050 of correction and characterize the middle ECG waveform 176C of ECG waveform when described conduit being placed shown in probe distal end portion icon 114, described right side window comprise the ECG trace 1050 of renewal and when described conduit finally being placed shown in probe distal end portion icon 114, characterize as described in the final position ECG waveform 176B of ECG waveform.Certainly, other configuration/information can be included in the described record.

As described herein, the various data of being obtained by using system 10 can be stored and/or assess, and are used for current or use after a while.Particularly, in one embodiment, the two can be stored that dawn, ground used with as is known to the person skilled in the art TLS magnetics trace data of being obtained by using system 10 and ECG signal detection data.In one embodiment, TLS magnetics trace data and ECG signal detection data at conduit 72 can be associated with the catheter position in the vascular system, as the function of time, so that the record placed of conduit can be fabricated in real time or carried out after a while by the storage of data.Such data can be stored in the conduit put procedure in real time, if operate with the fail-safe pattern when closing with described system between resting period temporarily or unpredictably.In addition, data can be useful in the following areas, promptly by calculating the distance between the position that current probe distal end position and P-wave amplitude be maximized, with respect to the correct position probe of the peak value P-wave amplitude position of ECG signal.Data can also be used to provide the three-dimensional information about such path, are pushed in patient's vascular system along the described conduit in described path.

Embodiment of the present invention can comprise special use or the general purpose computer with computer hardware.Embodiment in the scope of the present disclosure also comprises and is used to carry or make computer executable instructions or data structure to store thereon computer-readable medium.Such computer-readable medium can be for can be by any obtainable medium of universal or special computer access.Nonrestrictive in the mode of embodiment, computer-readable medium can comprise physics (or recordable type) computer-readable storage media, for example RAM, ROM, EEPROM, CD-ROM or other optical disk storage, disk memory or other magnetic storages, non-volatile and flash memories, the form with computer executable instructions or data structure of perhaps can being used to store expectation program code means and can be by any other medium of universal or special computer access.

In this description and appending claims, " network " is restricted to one or more data link that enables electronic data transfer between computer system and/or module.When information communicates to connect at network or another when being transmitted or providing to computer in (perhaps hardwired, wireless or hardwired or wireless combination), described computer is considered as computer-readable medium with described connection rightly.Therefore, in the mode of embodiment rather than restrictive, computer-readable medium can also comprise the link of such network or data, described network or data link can be used to the form carrying of computer executable instructions or data structure or store expectation program code means and can be by universal or special computer access.

Computer executable instructions comprises, for example causes general purpose computer, special-purpose computer or special processor to carry out the instruction and data of specific function or function group.Computer executable instructions can be, binary system intermediate format instructions (as assembler language or or even source code) for example.Although the present invention is described at architectural feature and/or method action, it being understood that the present invention who is limited in the appending claims need not to be restricted to described feature or above-mentioned action on language.On the contrary, described feature and action are disclosed as the exemplary form that realizes claim.

It will be appreciated by those skilled in the art that embodiment of the present invention can be put into practice under the computing environment with computer system configurations of one or more types (comprise personal computer, desktop PC, laptop computer, message handling device, hand-held device, multicomputer system, based on consumption electronic products microprocessor or programmable, online PC, mini-computer, host computer, mobile phone, PDA, pager or the like).Embodiment can also be put into practice under the distributed system environment of local and remote computer system (the two is all executed the task) by network linking (perhaps by hard-wired data link, wireless data link or the combination by hardwired and wireless data link).Under distributed system environment, program module can be arranged in local and remote memorizer memory devices the two.

Embodiment of the present invention can be implemented with other concrete forms, and do not depart from spirit of the present invention.The described embodiment of having described should be considered to be in everyway only be as illustrative and nonrestrictive.Thereby the scope of embodiment of the present invention is by appending claims but not aforementioned specification is shown.Implication and all changes in the equivalency range at claims are all answered within the scope of the invention involved.

Claims

1. catheter placement system that is used for conduit is inserted patient's vascular system, described system comprises:

Conduit tube component, described conduit tube component comprises:

The ECG sensor element, described ECG sensor element is used for when at least a portion of described conduit tube component is placed on described patient's vascular system, detects the ECG signal of described patient's heart knot;

The ECG signal receiving part, described ECG signal receiving part receives the ECG signal that is detected by described ECG sensor element, and described ECG signal receiving part operationally can be connected to described ECG sensor element; And

Connect the integrity parts, the exercisable connection of described connection integrity parts indication between described ECG signal receiving part and described ECG sensor element.

2. catheter placement system as claimed in claim 1, the described ECG sensor element of wherein said conduit tube component comprises the electrode on the probe that is included in the inner chamber that is received in conduit removedly, wherein said ECG sensor element also comprises at least one the outside ECG electrode on the parts of skin that is used to be placed on described patient, and wherein said ECG signal receiving part is set at described patient's outside.

3. catheter placement system as claimed in claim 2, wherein said at least one outside ECG electrode comprise first electrode and second electrode on the single disc that is positioned on the parts of skin that is used to be placed on described patient.

4. catheter placement system as claimed in claim 2, wherein said at least one outside ECG electrode comprise the image of the suitable placement location of described at least one the outside ECG electrode of indication on described patient's parts of skin.

5. catheter placement system as claimed in claim 1, also comprise display and the indicator icon that is included on the described display, wherein said indicator icon is indicated the state that is operatively connected between described ECG signal receiving part and the described ECG sensor element.

6. catheter placement system as claimed in claim 1, wherein said ECG signal receiving part operationally can be connected to described ECG sensor element via the physical connection between described ECG signal receiving part and the described ECG sensor element.

7. catheter placement system as claimed in claim 6, wherein said connection integrity parts comprise sensing circuit based on impedance, inductance sensing circuit, capacitance sensing circuit and based in the circuit of voltage at least one.

8. catheter placement system as claimed in claim 1, the described ECG sensor element of wherein said conduit tube component comprises the electrode on the probe that is included in the inner chamber that is received in conduit removedly, and described probe comprises and is used to detect whether cut assembly of described probe.

9. catheter placement system as claimed in claim 1, the described ECG sensor element of wherein said conduit tube component comprises the electrode on the probe that is included in the inner chamber that is received in conduit removedly, and described probe comprises the system that the distal end portion that is used to guarantee described probe aligns with the distal end portion of described conduit basically.

10. catheter placement system as claimed in claim 1 also comprises the foot switch of the one side that is used for controlling during use described catheter placement system function.

11. catheter placement system as claimed in claim 1, wherein said connection integrity parts comprise radiating element, and described radiating element is used to be transmitted in the last detectable signal of at least one lead-in wire of described ECG sensor element.

12. method that is used for showing the ECG signal data at catheter placement system, wherein said catheter placement system comprises that conduit tube component and being used for detects the ECG sensor element of described ECG signal data of described patient's knot when the conduit of described conduit tube component is set in patient's body at least in part, and described method comprises:

Described ECG signal data is sampled;

ECG signal data identification ECG waveform from described sampling;

Limit at least one parameter of the display window of described catheter placement system; And

According to described at least one parameter of described display window, in described display window, show described ECG waveform.

13. the method that is used to show as claimed in claim 12 shows that wherein the step of described ECG waveform also comprises:

When being allowed, make described ECG waveform and ECG waveform combination that at least one is previous by at least one parameter of described display window; And

When being allowed, in described display window, show described ECG waveform with described at least one previous ECG waveform by described at least one parameter of described display window.

14. the method that is used to show as claimed in claim 12, the step that wherein limits described at least one parameter also comprises:

According to limiting described at least one parameter of described display window by the control of user definition and at least one in dominant control.

15. the method that is used to show as claimed in claim 12, wherein said display window are included on the visual display unit of control station of described catheter placement system.

16. the method that is used to show as claimed in claim 12, the step that wherein limits described at least one parameter also comprises:

Qualification will be included in the number of the ECG waveform in the described display window.

17. the method that is used to show as claimed in claim 12, the step that wherein limits described at least one parameter also comprises:

Qualification will be at the time quantum of ECG waveform shown in the described display window.

18. method that is used for showing the ECG waveform at catheter placement system, wherein said catheter placement system comprises that conduit tube component and being used for detects the ECG sensor element of described ECG signal data of described patient's knot when the conduit of described conduit tube component is set in patient's body at least in part, and described method comprises:

Described ECG signal data is sampled;

ECG signal data identification ECG waveform from described sampling;

Identification and the relevant feature of described ECG waveform; And

Show described ECG waveform.

19. the method that is used to show as claimed in claim 18, the step of wherein discerning described feature also comprises:

Discern the P-ripple part of described ECG waveform.

20. the method that is used to show as claimed in claim 19, the step of wherein discerning described P-ripple part comprises the part and known P-mode plate of more described ECG waveform.

21. the method that is used to show as claimed in claim 18 shows that wherein the step of described ECG waveform also comprises:

When showing described ECG waveform, visually highlight the P-ripple part of described ECG waveform.

22. the method that is used to show as claimed in claim 18 also comprises:

Discern the QRS wave group of described ECG waveform; And

Determine the ratio between the size of the size of described P-ripple part and described QRS wave group; And

Utilize the data show described ECG waveform relevant with described ratio.

23. the method that is used to show as claimed in claim 18 also comprises:

Described ECG waveform fixes on the display of described catheter placement system in response to the input of user.

24. the method that is used to show as claimed in claim 18 also comprises:

The data relevant with described ECG waveform are stored in the storage location.

25. being recycled, the method that is used to show as claimed in claim 18, wherein said method show successive ECG waveform.

26. the method that is used to show as claimed in claim 18 also comprises:

Produce visual in response to the feature of described ECG waveform or audible output.

27. computer program, described computer program is used for realizing storing and the method for using catheter placement system in the relevant information of the conduit of patient's vascular system placement conduit tube component, described conduit tube component comprises the ECG sensor element of the ECG signal data of the knot that detects the patient when being used in described conduit is set at described patient's body at least in part, and generation can be by the magnetic field of described catheter placement system detection or the magnetics of electromagnetic field, described computer program comprises that having computer executable instructions is stored in described one or more computer-readable medium on one or more computer-readable medium, described computer executable instructions causes described computer system to be achieved as follows content when being carried out by processor:

Described ECG signal data is sampled;

Magnetic field data to described magnetics is sampled;

Described ECG signal data and described magnetic field data are associated with the position of the intravital described conduit of described patient; And

Store described ECG signal data and the magnetic field data that is associated.